Fasting-Refedding Cycle for Obesity
(DIP Trial)
Recruiting in Palo Alto (17 mi)
Overseen byFranck Mauvais-Jarvis, MD, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Pennington Biomedical Research Center
Must not be taking: GLP-1 agonists, Metformin, Amphetamines, others
Disqualifiers: Eating disorders, Diabetes, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either low body weight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that affect energy intake or expenditure, like semaglutide or metformin, to participate in this trial. The protocol doesn't specify a washout period, but it's best to discuss with the trial team.
What data supports the effectiveness of the fasting-refeeding cycle treatment for obesity?
Research shows that alternate day modified fasting can effectively help with weight loss in obese adults. Additionally, a study found that a longer refeeding period after a very-low-energy diet helps maintain weight loss better over a year.
12345Is the fasting-refeeding cycle generally safe for humans?
The studies reviewed do not directly address the safety of fasting-refeeding cycles in humans, but they suggest that refeeding after fasting can help maintain weight loss and improve eating behavior. However, the long-term effects and safety in humans are not clearly established, and more research is needed to understand potential risks.
56789How does the fasting-refeeding cycle treatment for obesity differ from other treatments?
The fasting-refeeding cycle treatment for obesity is unique because it involves alternating periods of fasting and eating freely, which can lead to increased food efficiency and rapid weight regain due to the body's energy conservation mechanisms. This approach contrasts with continuous caloric restriction, which often leads to long-term weight regain due to hormonal and metabolic changes.
168910Eligibility Criteria
This trial is for men and women aged 20-40 with stable body weight who are either underweight (BMI < 18.5) or obese (BMI ≥ 30). Participants must have normal thyroid, blood count, and chemistry levels, enjoy Ensure Plus drinks to some extent, and women should not have given birth and must have regular menstrual cycles.Inclusion Criteria
My BMI is either below 18.5 or above 30.
I am between 20 and 40 years old.
My blood tests for thyroid, blood count, and chemistry are normal.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Inpatient Energy Balance
Participants are maintained in metabolic chambers for 1 day of energy balance
1 day
Inpatient stay
Fasting
Participants undergo 2 days of fasting to measure compensatory responses
2 days
Inpatient stay
Ad-libitum Refeeding
Participants undergo 2 days of ad-libitum refeeding to measure compensatory responses
2 days
Inpatient stay
Follow-up
Participants are monitored for safety and effectiveness after the fasting-refeeding cycle
1-2 weeks
Participant Groups
The study tests how the human body regulates weight by having participants go through a fasting-refeeding cycle: two days of fasting followed by two days where they can eat as much as they want. Their energy intake and expenditure will be measured in metabolic chambers.
1Treatment groups
Experimental Treatment
Group I: Fasting-refeeding cycleExperimental Treatment1 Intervention
Participants will be maintained in metabolic chambers and exposed to 1 day of energy balance, 2 days of fasting, and 2 days of ad-libitum refeeding.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Pennington Biomedical Research CenterBaton Rouge, LA
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Who Is Running the Clinical Trial?
Pennington Biomedical Research CenterLead Sponsor
Tulane UniversityCollaborator
References
Dietary and physical activity adaptations to alternate day modified fasting: implications for optimal weight loss. [2021]Alternate day modified fasting (ADMF) is an effective strategy for weight loss in obese adults.
Weight cycling in adults with severe obesity: A longitudinal study. [2019]Although weight cycling is a common phenomenon in treatment-seeking patients with obesity, its consequences on health outcomes have not yet been completely clarified. We therefore aimed to investigate the effect of one cycle of intentional weight loss and regain on energy expenditure, body composition, cardiovascular risk factors and psychosocial variables in patients with severe obesity.
Weight loss and biomedical health improvement on a very low calorie diet: the moderating role of history of weight cycling. [2016]In this study, the authors examined biomedical consequences of participation in a professionally delivered, multifaceted very low calorie diet (VLCD) program and whether the degree of benefit associated with treatment was moderated by history of weight cycling. The authors monitored body weight and biomedical health indicators in 66 severely obese outpatients on a VLCD liquid fast. Participants remained on the VLCD for a median of 55 (range 9 to 247) days. Treatment was associated with significant pre-to-post improvements on body weight, systolic and diastolic blood pressure, triglycerides, and cholesterol. History of weight cycling (independent of age) was inversely related to the magnitude of absolute pre-to-post treatment changes in systolic and diastolic blood pressure, as well as to the rate of weight change. More intensive, longer term, and explicit maintenance components, especially aimed at individuals with multiple weight loss-regain episodes, may be necessary to facilitate weight loss and attain optimal health benefits from VLCDs.
Retrospective long-term comparison of naturopathic fasting therapy and weight reduction diet in overweight patients. [2021]In a follow-up study overweight and obese patients fasting according to Buchinger (modified) and a control group treated by a weight reduction diet in the context of an inpatient naturopathic complex treatment were compared using a questionnaire developed for a standardized phone interview 6.8 ± 1.1 years after inpatient treatment. During the inpatient treatment the fasting patients significantly more body weight, but at the time of the interview significantly more weight was gained again. 10.7% of the fasting patients and 31.9% of the control group lowered their weight at least 5% of their initial weight up to the interview. 42% of the fasting and 74% of the control group persistently changed their diet. The control group followed a significantly higher number of trained nutritional aspects. 21% of the fasting and 40% of the control group increased their leisure activity permanently. Continued improvement in quality of life was achieved by 16% of the fasting patients and 28% of the control group. The fasting therapy, carried out as part of the inpatient naturopathic complex treatment, turned out to be less suitable for the treatment of overweight and obesity compared to standard therapy. One likely determinant is the minor poststationary lifestyle modification.
Prolonged refeeding improves weight maintenance after weight loss with very-low-energy diets. [2021]The aim of the present study was to test the hypothesis that a prolonged refeeding duration after successful very-low-energy diet (VLED)-induced weight loss beneficially affects weight development and eating behaviour. Patients (n 269) were recruited to a 1-year obesity treatment programme with 12 weeks of an initial VLED. After the VLED, patients with >or= 10 % weight loss were randomly allocated to 1 week (group 1) or 6 weeks (group 6) refeeding to an ordinary, energy-reduced diet, and thereafter followed and actively treated for an additional 40 weeks. Eating behaviour (revised twenty-one-item Three-Factor Eating Questionnaire) was measured at baseline, during and after refeeding, and at week 52. Weight change over time in the two treatment groups was tested by repeated-measures analysis in completers and by intention to treat (ITT). Of the patients, 169 (109 women) lost >or= 10 % during the VLED and were randomised. At randomisation, weight loss was - 16.5 (SD 3.7) % in group 1 and - 16.7 (SD 4.3) % in group 6 (P = 0.73). Between weeks 12 and 52, completers in group 6 regained significantly less weight (3.9 (SD 9.1) %) as compared with group 1 (8.2 (SD 8.3) %; P = 0.006) (ITT, P = 0.05). Completers in group 6 also maintained a higher level of dietary restraint after refeeding was completed, but eating behaviour did not differ at week 52. Weight change after the refeeding periods were completed did not differ significantly between the groups (P = 0.06). Overall, longer refeeding duration after successful weight loss with a VLED improves weight maintenance in a 1-year perspective.
Refeeding after fasting in the rat: effects on body composition and food efficiency. [2018]Adult male Sprague-Dawley rats were fasted for 65 h and then refed ad libitum for 8 days, during which time body weight and body composition returned to the levels of nonfasting controls. During refeeding, after a decrease on the lst day, daily food intake was moderately increased above control levels. This compensatory increase after the fast brought the total consumption for the whole period to the same level as for the controls. Thus, a greater body weight increase per gram food consumed ("food efficiency") was achieved during the refeeding period. Starvation-induced energy conservation processes thus seemed to persist during refeeding. This mechanism(s) might participate in causing weight gain after reduction as a treatment for obesity.
Rationale for novel intermittent dieting strategies to attenuate adaptive responses to energy restriction. [2019]Eating patterns involving intermittent energy restriction (IER) include 'intermittent fasting' where energy intake is severely restricted for several 'fasting' days per week, with 'refeeding' days (involving greater energy intake than during fasting days) at other times. Intermittent fasting does not improve weight loss compared to continuous energy restriction (CER), where energy intake is restricted every day. We hypothesize that weight loss from IER could be improved if refeeding phases involved restoration of energy balance (i.e. not ongoing energy restriction, as during intermittent fasting). There is some evidence in adults with overweight or obesity showing that maintenance of a lower weight may attenuate (completely or partially) some of the adaptive responses to energy restriction that oppose ongoing weight loss. Other studies show some adaptive responses persist unabated for years after weight loss. Only five randomized controlled trials in adults with overweight or obesity have compared CER with IER interventions that achieved energy balance (or absence of energy restriction) during refeeding phases. Two reported greater weight loss than CER, whereas three reported similar weight loss between interventions. While inconclusive, it is possible that achieving energy balance (i.e. avoiding energy restriction or energy excess) during refeeding phases may be important in realizing the potential of IER.
Body mass cycling and predictors of body mass regain and its impact on cardiometabolic health. [2021]Caloric restriction (CR) is the first line intervention to reduce adiposity and total body mass (BM) to improve insulin resistance and ameliorate metabolic derangements. However, the lost adipose mass is difficult to maintain reduced in the long term due to several factors including compensatory changes in orexigenic hormones, adipokine release, pro-inflammatory state, adipose tissue morphology, and resting metabolic rate as a consequence of the caloric deficit. Hence, most patients undergoing a BM reduction intervention ultimately regain the lost mass and too often additional adipose mass overtime, which is hypothesized to have increased deleterious effects chronically. In this mini-review we describe the effects of BM cycling (loss and regain) on insulin resistance and cardiometabolic health and factors that may predict BM regain in clinical studies. We also describe the factors that contribute to the chronic deleterious effects of BM cycling in rodent models of diet-induced obesity (DIO) and other metabolic defects. We conclude that most of the improvements in insulin resistance are observed after a profound loss in BM regardless of the diet and that BM cycling abrogates these beneficial effects. We also suggest that more BM cycling studies are needed in rodent models resembling the development of type 2 diabetes mellitus (T2DM) in humans.
Plasticity of adipose tissue in response to fasting and refeeding in male mice. [2020]Fasting is the most widely prescribed and self-imposed strategy for treating excessive weight gain and obesity, and has been shown to exert a number of beneficial effects. The aim of the present study was to determine the exact role of fasting and subsequent refeeding on fat distribution in mice.
Fatty acid oxidation and fatty acid synthesis in energy restricted rats(1). [2019]The importance of fat oxidation and fatty acid synthesis were examined in rats fed approximately one half their ad libitum food intake for a period of 13 days followed by 7 days of ad libitum feeding (refed rats). This study was undertaken because previous reports demonstrated that refed rats rapidly accumulated body fat. Our results confirmed this observation: refed rats accrued body fat and body weight at rates that were approximately 3 times higher than controls. Evidence for a period of increased metabolic efficiency was demonstrated by measuring the net energy requirement for maintenance over the refeeding period: refed rats had a reduced metabolic rate during the period of energy restriction (approximately 30% lower than control) and this persisted up to 2 days after the reintroduction of ad libitum feeding. The major factor responsible for the rapid fat gain was a depressed rate of fatty acid oxidation. Calculations of protein and carbohydrate intake over the refeeding period showed that the simplest explanation for the decrease in fatty acid oxidation is fat sparing. This is possible because of the large increase in dietary carbohydrate and protein intake during the refeeding period when metabolic rates are still depressed. The increased carbohydrate and protein may adequately compensate for the increasing energy requirements of the ER rats over the refeeding period affording rats the luxury of storing the excess dietary fat energy.