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Albert Goday - One of the best experts on this subject based on the ideXlab platform.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional Weight Loss Program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional Weight Loss (VLCK diet), and 44 to the standard low-calorie diet. No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight Loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. The interventional Weight Loss Program based on a VLCK diet is most effective in reducing body Weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Rena R Wing - One of the best experts on this subject based on the ideXlab platform.
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food reward sensitivity impulsivity and Weight change during and after a 3 month Weight Loss Program
PLOS ONE, 2020Co-Authors: Kathryn M Ross, Abraham Eastman, Umelo A Ugwoaba, Kathryn E Demos, Jason Lillis, Rena R WingAbstract:Background Greater sensitivity to food rewards and higher levels of impulsivity (and an interaction between these variables, termed “reinforcement pathology”) have been associated with obesity in cross-sectional studies. Less is known regarding how these constructs may impact attempts at Weight Loss or longer-term Weight Loss maintenance. Methods We provided 75 adults (69%Female, 84%White, age = 50.8y, BMI = 31.2kg/m2) with a 3-month Internet-based Weight Loss Program and assessed Weight, food reward sensitivity (via the Power of Food Scale [PFS]), and impulsivity (via Go No-Go [GNG] and Delay Discounting [DD] computer tasks) at baseline and at Months 3, 6, 9, and 12. No additional intervention was provided Months 3–12. Multi-level mixed-effect models were used to examine changes in PFS, GNG, and DD over time and associations between these measures and Weight Loss/regain. Results Participants lost 6.0±1.1kg Months 0–3 and regained 2.4±1.1kg Months 3–12. Across time points, higher PFS scores were associated with higher Weight, p = .007; however, there were no significant associations between GNG or DD and Weight nor between the interactions of PFS and GNG or DD and Weight, ps>.05. There were significant decreases from Months 0–3 in PFS, GNG, and DD, ps .05. Conclusion Results demonstrated an association between food reward sensitivity and Weight. Further, decreases in both food reward sensitivity and impulsivity were observed during an initial Weight Loss Program, but neither baseline levels nor improvements were associated with Weight change. Taken together, results suggest that the constructs of food reward sensitivity, impulsivity, and reinforcement pathology may have limited clinical utility within behavioral Weight management interventions. Future intervention studies should examine whether food-related impulsivity tasks lead to a similar pattern of results.
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a preliminary investigation into whether early intervention can improve Weight Loss among those initially non responsive to an internet based behavioral Program
Journal of Behavioral Medicine, 2016Co-Authors: Jessica L Unick, Leah Dorfman, Tricia M Leahey, Rena R WingAbstract:This study examined whether providing additional support to individuals with poor initial Weight Loss improves 12-week outcomes. Participants were randomized to a 12-week internet-delivered behavioral Weight Loss Program (IBWL; n = 50) or the identical internet Program plus the possibility of extra support (IBWL + ES; n = 50). IBWL + ES participants losing 0.05). Providing additional intervention to early non-responders in an Internet Program improves treatment outcomes.
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randomized controlled trial of a comprehensive home environment focused Weight Loss Program for adults
Health Psychology, 2013Co-Authors: Amy A Gorin, Hollie A Raynor, Joseph L Fava, Kimberly Maguire, Erica Ferguson Robichaud, Jennifer Trautvetter, Melissa M Crane, Rena R WingAbstract:The prevalence of overWeight and obesity in U.S. adults now exceeds 65% (Flegal, Carroll, Ogden, & Curtin, 2010) with current estimates suggesting that the entire U.S. adult population will reach an unhealthy Weight status by 2048 (Wang, Beydoun, Liang, Caballero, & Kumanyika, 2008). Drivers of this trend are multi-faceted, ranging from individual behavioral choices to community land-use planning decisions to global food production practices that promote energy imbalance (e.g., Swinburn et al., 2011). Behavioral Weight Loss treatment (BWL), the treatment of choice for overWeight to moderately obese individuals, includes nutrition and physical activity education and instruction in behavioral strategies to facilitate change, and produces Weight Losses of approximately 9.0 kg over 6 months of treatment (e.g., Wing, Gorin, & Tate, 2006). While BWL’s modest Weight Losses and accompanying physical activity and dietary changes produce meaningful health improvements (e.g., Diabetes Prevention Program Research Group, 2002; Look AHEAD Research Group, 2007), participants typically regain 30–50% of their Weight Loss over the next 3 to 5 years despite ongoing intervention (e.g., Look AHEAD Research Group, 2010). One possible explanation for this Weight regain is that BWL focuses primarily on the individual participant, with lesser attention paid to the environmental context in which eating and exercise occurs. While behavioral theory and early Weight Loss Programs emphasized the impact of environmental antecedents and consequences on behavior (e.g., Stuart & Davis, 1972), in current practice, individuals are given limited instruction on how to modify their surroundings to support Weight-regulating behaviors. In a standard 6-month Program, 1 to 2 sessions are typically dedicated to stimulus control skills (e.g. placing fruits and vegetables in prominent locations), (Wing, Gorin, & Tate, 2006). If Weight Loss participants are unable to use these skills to alter their personal environments, unhealthy cues and temptations may remain making it extremely difficult to establish and maintain the behavioral changes necessary to produce long-term Weight Loss (e.g., Bouton, 2000; Lowe, 2003). This individual-level approach to Weight management is inconsistent with the growing recognition of the environment’s contribution to the obesity epidemic (e.g., French, Story, & Jeffery, 2001; Swinburn et al., 2011). American adults are described as living in a “toxic environment” that encourages passive overeating and physical inactivity (Wang & Brownell, 2005). Social ecological models of health promotion (Breslow, 1996; Stokols, 2000) identify several levels of environmental influence on diet and physical activity, ranging from familial to global factors. At the most proximal level, there is increasing evidence that the home microenvironment can be obesogenic. Both physical (e.g., type of food available) and social (e.g., support from family) factors in this setting have been associated with Weight, dietary habits, and activity patterns (e.g., Campbell, Crawford, Salmon, Carver, Garnett, & Baur, 2007; Gorin, Phelan, Raynor, & Wing, 2011). Demonstrated links between the physical home environment and behavior include relationships between high fat foods available and fat intake (Fulkerson et al., 2008), access to home exercise equipment and activity levels (Gattshall et al., 2008; Jakicic, Wing, Butler, & Jeffery, 1997), and number of televisions and amount of TV viewing (Dennison, Erb, & Jenkins, 2002). With regards to social factors, adults within the same household can serve as powerful behavioral cues and either facilitate or hinder adoption of healthy habits. For example, both Weight gain and Weight Loss appear to spread among spouses (Christakis & Fowler, 2007; Gorin et al., 2008) and correlations have been reported between husbands and wives in caloric intake, dietary restraint, and exercise frequency (e.g., Macken et al., 2000; Markey, Markey, & Birch, 2001). Given that approximately two-thirds of daily calories are consumed in the home and a large percentage of leisure time is spent in this environment (Biing-Hwan, Geuthri, & Frazao, 1999; Robinson & Godbey, 1997), modifying households to promote healthy choices is a logical step in moving toward a broader ecological model of Weight management. Weight Loss Programs that have included home environment modifications such as food provision, provision of exercise equipment, and involving spouses in treatment have produced better overall Weight Losses for up to 18 months than standard behavioral Programs, particularly in women (Black, Gleser, & Kooyers, 1990; Jakicic, Winters, Lang, & Wing, 1999); however these strategies have been largely unsuccessful in producing better maintenance of Weight Loss. Environmental manipulations to date have typically focused on either a single physical factor in the home (such as provision of food or exercise equipment) or on the social climate of the home (spouse involvement in treatment). This singular focus may not change the overall obesogenic nature of the household, leaving participants vulnerable to environmental influence. Moreover, this singular focus does not address the interaction between physical and social factors within the home (e.g., food provision may be unsuccessful if family members bring tempting foods into the home). Ecological models suggest that interventions will be most effective in changing behavior if they address multiple factors within a given environment, thus to examine the true potential of home environment manipulations in obesity treatment, a more comprehensive intervention targeting several aspects within the household may be needed. The primary aim of this randomized controlled trial was to examine the long-term impact of a comprehensive home-focused behavioral Weight control Program designed to directly modify both the physical and social home environments of Weight Loss participants. To our knowledge, this is the first Weight Loss Program to intervene simultaneously on multiple levels of the home environment while also teaching participants core behavioral skills. We hypothesized that by extending the focus of treatment from the individual participant to the participant plus their home environment, the intervention would enhance initial and long-term Weight Loss outcomes and improve maintenance of Weight Loss compared to standard behavioral Weight Loss treatment. Prior research has suggested that women may benefit more from a home-based approach (Wing, Marcus, Epstein, & Jawad, 1991), thus secondary analyses explored gender as a potential treatment moderator. We also examined potential effects on household partners and hypothesized that greater Weight Loss and behavior changes would be observed in partners who were actively included in the intervention.
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randomized controlled trial of a comprehensive home environment focused Weight Loss Program for adults
Health Psychology, 2013Co-Authors: Amy A Gorin, Hollie A Raynor, Joseph L Fava, Kimberly Maguire, Jennifer Trautvetter, Melissa M Crane, Erica Robichaud, Rena R WingAbstract:The prevalence of overWeight and obesity in U.S. adults now exceeds 65% (Flegal, Carroll, Ogden, & Curtin, 2010) with current estimates suggesting that the entire U.S. adult population will reach an unhealthy Weight status by 2048 (Wang, Beydoun, Liang, Caballero, & Kumanyika, 2008). Drivers of this trend are multi-faceted, ranging from individual behavioral choices to community land-use planning decisions to global food production practices that promote energy imbalance (e.g., Swinburn et al., 2011). Behavioral Weight Loss treatment (BWL), the treatment of choice for overWeight to moderately obese individuals, includes nutrition and physical activity education and instruction in behavioral strategies to facilitate change, and produces Weight Losses of approximately 9.0 kg over 6 months of treatment (e.g., Wing, Gorin, & Tate, 2006). While BWL’s modest Weight Losses and accompanying physical activity and dietary changes produce meaningful health improvements (e.g., Diabetes Prevention Program Research Group, 2002; Look AHEAD Research Group, 2007), participants typically regain 30–50% of their Weight Loss over the next 3 to 5 years despite ongoing intervention (e.g., Look AHEAD Research Group, 2010). One possible explanation for this Weight regain is that BWL focuses primarily on the individual participant, with lesser attention paid to the environmental context in which eating and exercise occurs. While behavioral theory and early Weight Loss Programs emphasized the impact of environmental antecedents and consequences on behavior (e.g., Stuart & Davis, 1972), in current practice, individuals are given limited instruction on how to modify their surroundings to support Weight-regulating behaviors. In a standard 6-month Program, 1 to 2 sessions are typically dedicated to stimulus control skills (e.g. placing fruits and vegetables in prominent locations), (Wing, Gorin, & Tate, 2006). If Weight Loss participants are unable to use these skills to alter their personal environments, unhealthy cues and temptations may remain making it extremely difficult to establish and maintain the behavioral changes necessary to produce long-term Weight Loss (e.g., Bouton, 2000; Lowe, 2003). This individual-level approach to Weight management is inconsistent with the growing recognition of the environment’s contribution to the obesity epidemic (e.g., French, Story, & Jeffery, 2001; Swinburn et al., 2011). American adults are described as living in a “toxic environment” that encourages passive overeating and physical inactivity (Wang & Brownell, 2005). Social ecological models of health promotion (Breslow, 1996; Stokols, 2000) identify several levels of environmental influence on diet and physical activity, ranging from familial to global factors. At the most proximal level, there is increasing evidence that the home microenvironment can be obesogenic. Both physical (e.g., type of food available) and social (e.g., support from family) factors in this setting have been associated with Weight, dietary habits, and activity patterns (e.g., Campbell, Crawford, Salmon, Carver, Garnett, & Baur, 2007; Gorin, Phelan, Raynor, & Wing, 2011). Demonstrated links between the physical home environment and behavior include relationships between high fat foods available and fat intake (Fulkerson et al., 2008), access to home exercise equipment and activity levels (Gattshall et al., 2008; Jakicic, Wing, Butler, & Jeffery, 1997), and number of televisions and amount of TV viewing (Dennison, Erb, & Jenkins, 2002). With regards to social factors, adults within the same household can serve as powerful behavioral cues and either facilitate or hinder adoption of healthy habits. For example, both Weight gain and Weight Loss appear to spread among spouses (Christakis & Fowler, 2007; Gorin et al., 2008) and correlations have been reported between husbands and wives in caloric intake, dietary restraint, and exercise frequency (e.g., Macken et al., 2000; Markey, Markey, & Birch, 2001). Given that approximately two-thirds of daily calories are consumed in the home and a large percentage of leisure time is spent in this environment (Biing-Hwan, Geuthri, & Frazao, 1999; Robinson & Godbey, 1997), modifying households to promote healthy choices is a logical step in moving toward a broader ecological model of Weight management. Weight Loss Programs that have included home environment modifications such as food provision, provision of exercise equipment, and involving spouses in treatment have produced better overall Weight Losses for up to 18 months than standard behavioral Programs, particularly in women (Black, Gleser, & Kooyers, 1990; Jakicic, Winters, Lang, & Wing, 1999); however these strategies have been largely unsuccessful in producing better maintenance of Weight Loss. Environmental manipulations to date have typically focused on either a single physical factor in the home (such as provision of food or exercise equipment) or on the social climate of the home (spouse involvement in treatment). This singular focus may not change the overall obesogenic nature of the household, leaving participants vulnerable to environmental influence. Moreover, this singular focus does not address the interaction between physical and social factors within the home (e.g., food provision may be unsuccessful if family members bring tempting foods into the home). Ecological models suggest that interventions will be most effective in changing behavior if they address multiple factors within a given environment, thus to examine the true potential of home environment manipulations in obesity treatment, a more comprehensive intervention targeting several aspects within the household may be needed. The primary aim of this randomized controlled trial was to examine the long-term impact of a comprehensive home-focused behavioral Weight control Program designed to directly modify both the physical and social home environments of Weight Loss participants. To our knowledge, this is the first Weight Loss Program to intervene simultaneously on multiple levels of the home environment while also teaching participants core behavioral skills. We hypothesized that by extending the focus of treatment from the individual participant to the participant plus their home environment, the intervention would enhance initial and long-term Weight Loss outcomes and improve maintenance of Weight Loss compared to standard behavioral Weight Loss treatment. Prior research has suggested that women may benefit more from a home-based approach (Wing, Marcus, Epstein, & Jawad, 1991), thus secondary analyses explored gender as a potential treatment moderator. We also examined potential effects on household partners and hypothesized that greater Weight Loss and behavior changes would be observed in partners who were actively included in the intervention.
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using internet technology to deliver a behavioral Weight Loss Program
JAMA, 2001Co-Authors: Deborah F Tate, Rena R Wing, Richard A WinettAbstract:ContextRapid increases in access to the Internet have made it a viable mode for public health intervention. No controlled studies have evaluated this resource for Weight Loss.ObjectiveTo determine whether a structured Internet behavioral Weight Loss Program produces greater initial Weight Loss and changes in waist circumference than a Weight Loss education Web site.DesignRandomized, controlled trial conducted from April to December 1999.Setting and ParticipantsNinety-one healthy, overWeight adult hospital employees aged 18 to 60 years with a body mass index of 25 to 36 kg/m2. Analyses were performed for the 65 who had complete follow-up data.InterventionsParticipants were randomly assigned to a 6-month Weight Loss Program of either Internet education (education; n = 32 with complete data) or Internet behavior therapy (behavior therapy; n = 33 with complete data). All participants were given 1 face-to-face group Weight Loss session and access to a Web site with organized links to Internet Weight Loss resources. Participants in the behavior therapy group received additional behavioral procedures, including a sequence of 24 weekly behavioral lessons via e-mail, weekly online submission of self-monitoring diaries with individualized therapist feedback via e-mail, and an online bulletin board.Main Outcome MeasuresBody Weight and waist circumference, measured at 0, 3, and 6 months, compared the 2 intervention groups.ResultsRepeated-measures analyses showed that the behavior therapy group lost more Weight than the education group (P = .005). The behavior therapy group lost a mean (SD) of 4.0 (2.8) kg by 3 months and 4.1 (4.5) kg by 6 months. Weight Loss in the education group was 1.7 (2.7) kg at 3 months and 1.6 (3.3) kg by 6 months. More participants in the behavior therapy than education group achieved the 5% Weight Loss goal (45% vs 22%; P = .05) by 6 months. Changes in waist circumference were also greater in the behavior therapy group than in the education group at both 3 months (P = .001) and 6 months (P = .005).ConclusionsParticipants who were given a structured behavioral treatment Program with weekly contact and individualized feedback had better Weight Loss compared with those given links to educational Web sites. Thus, the Internet and e-mail appear to be viable methods for delivery of structured behavioral Weight Loss Programs.
Felipe F Casanueva - One of the best experts on this subject based on the ideXlab platform.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional Weight Loss Program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional Weight Loss (VLCK diet), and 44 to the standard low-calorie diet. No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight Loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. The interventional Weight Loss Program based on a VLCK diet is most effective in reducing body Weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Ignacio Sajoux - One of the best experts on this subject based on the ideXlab platform.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional Weight Loss Program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional Weight Loss (VLCK diet), and 44 to the standard low-calorie diet. No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight Loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. The interventional Weight Loss Program based on a VLCK diet is most effective in reducing body Weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Basilio Moreno - One of the best experts on this subject based on the ideXlab platform.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional Weight Loss Program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional Weight Loss (VLCK diet), and 44 to the standard low-calorie diet. No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight Loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. The interventional Weight Loss Program based on a VLCK diet is most effective in reducing body Weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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short term safety tolerability and efficacy of a very low calorie ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
Nutrition & Diabetes, 2016Co-Authors: Albert Goday, D Bellido, Ignacio Sajoux, Ana B Crujeiras, Bartolome Burguera, Pedro Pablo Garcialuna, A Oleaga, Basilio Moreno, Felipe F CasanuevaAbstract:Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional Weight Loss Program versus hypocaloric diet in patients with type 2 diabetes mellitus
