Trial Summary
What is the purpose of this trial?Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.
Is intermittent fasting a promising treatment for prediabetes and obesity?Yes, intermittent fasting is a promising treatment for prediabetes and obesity. Studies show it can help with weight loss and is as effective as other methods like continuous calorie reduction. It is also considered feasible and acceptable for managing obesity.23478
What safety data exists for intermittent fasting in treating prediabetes and obesity?The safety of intermittent fasting (IF) compared to continuous energy-restricted diets (CERD) has been evaluated in patients with type 2 diabetes mellitus and metabolic syndrome, showing similar effects on glycemic control and weight loss. Studies indicate that intermittent energy restriction (IER) strategies, including intermittent fasting and time-restricted feeding, produce equivalent weight loss to continuous energy restriction without significant differences in safety outcomes. Additionally, IER is considered a feasible, effective, and acceptable intervention for obesity management, with no compensatory increases in appetite or eating behavior observed in women with overweight and obesity.12357
What data supports the idea that Intermittent Fasting for Prediabetes and Obesity is an effective treatment?The available research shows that intermittent fasting (IF) can be as effective as continuous calorie reduction (CER) for weight loss in people with obesity. In studies comparing these methods, most found no significant difference in weight or body fat loss between the two. This suggests that IF is a viable alternative to traditional calorie-restricted diets for managing obesity. Additionally, IF has been shown to be a feasible and acceptable approach for treating obesity in both adults and adolescents.12367
Do I have to stop taking my current medications?Yes, you must stop taking chronic medications, including oral contraceptive pills, to participate in this trial.
Eligibility Criteria
This trial is for men and women aged 25-45 with a BMI between 21-29, normal thyroid function, regular menstrual cycles for women, and a family history of type 2 diabetes. It's not suitable for those on chronic medications, pregnant or breastfeeding individuals, people with certain vitamin deficiencies or high cholesterol risks, those with eating disorders or substance abuse issues.Inclusion Criteria
I am between 25 and 45 years old.
My thyroid function is normal.
I have regular menstrual cycles.
Exclusion Criteria
I have a long-term illness like high blood pressure or Type 2 diabetes.
I need medication to lower my cholesterol as per AHA guidelines.
I am on long-term medications or birth control pills.
Treatment Details
The study examines the metabolic effects of intermittent fasting without daily dietary restrictions to see if benefits like weight loss are independent of fasting itself. Participants will undergo fasting protocols alongside counseling sessions aimed at maintaining their current weight.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Fasting with weight maintenanceExperimental Treatment2 Interventions
Subjects will fast one-day per week for 12 weeks and maintain body weight
Group II: FastingExperimental Treatment1 Intervention
Subjects will fast one-day per week for 12 weeks
Group III: CounselingPlacebo Group1 Intervention
Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)
Find a clinic near you
Research locations nearbySelect from list below to view details:
UPMC MontefiorePittsburgh, PA
University of PittsburghPittsburgh, PA
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Who is running the clinical trial?
University of PittsburghLead Sponsor
References
Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. [2022]Are intermittent fasting interventions an effective treatment for overweight and obesity in adults, when compared to usual care treatment (continuous daily energy restriction - reduced calorie diet) or no treatment (ad libitum diet)?
Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. [2023]Intermittent energy restriction (IER) is an effective obesity management strategy in adults.
Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. [2021]The current obesity epidemic is staggering in terms of its magnitude and public health impact. Current guidelines recommend continuous energy restriction (CER) along with a comprehensive lifestyle intervention as the cornerstone of obesity treatment, yet this approach produces modest weight loss on average. Recently, there has been increased interest in identifying alternative dietary weight loss strategies that involve restricting energy intake to certain periods of the day or prolonging the fasting interval between meals (i.e., intermittent energy restriction, IER). These strategies include intermittent fasting (IMF; >60% energy restriction on 2-3 days per week, or on alternate days) and time-restricted feeding (TRF; limiting the daily period of food intake to 8-10 h or less on most days of the week). Here, we summarize the current evidence for IER regimens as treatments for overweight and obesity. Specifically, we review randomized trials of ≥8 weeks in duration performed in adults with overweight or obesity (BMI ≥ 25 kg/m2) in which an IER paradigm (IMF or TRF) was compared to CER, with the primary outcome being weight loss. Overall, the available evidence suggests that IER paradigms produce equivalent weight loss when compared to CER, with 9 out of 11 studies reviewed showing no differences between groups in weight or body fat loss.
Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol. [2021]Intermittent energy restriction (IER) has shown early success in adolescents with obesity, however efficacy trials are needed. This study aims to determine if IER results in lower body mass index (BMI) z-score after 52 weeks in metabolically unhealthy adolescents with obesity compared with continuous energy restriction (CER).
Matched Weight Loss Through Intermittent or Continuous Energy Restriction Does Not Lead To Compensatory Increases in Appetite and Eating Behavior in a Randomized Controlled Trial in Women with Overweight and Obesity. [2023]Continuous energy restriction (CER) is purported to be problematic because of reductions in fat-free mass (FFM), compensatory motivation to overeat, and weakened satiety. Intermittent energy restriction (IER) is an alternative behavioral weight loss (WL) strategy that may mitigate some of these limitations.
Intermittent fasting and weight loss: Systematic review. [2021]To examine the evidence for intermittent fasting (IF), an alternative to calorie-restricted diets, in treating obesity, an important health concern in Canada with few effective office-based treatment strategies.
Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. [2021]To compare the safety of intermittent fasting (IF) with that of continuous energy-restricted diets (CERD) in patients with T2DM and metabolic syndrome who were overweight or obese and assess their effects on glycemic control and weight loss.
Differential effects of intermittent energy restriction vs. continuous energy restriction combined high-intensity interval training on overweight/obese adults: A randomized controlled trial. [2022]Intermittent energy restriction (IER) and continuous energy restriction (CER) are increasingly popular dietary approaches used for weight loss and overall health. These energy restriction protocols combined with exercise on weight loss and other health outcomes could achieve additional effects in a short-term intervention.