Intermittent Fasting for Prediabetes and Obesity

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Pouneh Fazeli, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Must not be taking: Chronic medications

Disqualifiers: Hypertension, Type 2 diabetes, others

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.

Will I have to stop taking my current medications?

Yes, participants must stop taking chronic medications, including oral contraceptive pills, to join this trial.

What data supports the effectiveness of the treatment Intermittent Fasting for Prediabetes and Obesity?

Research shows that intermittent fasting (IF) can be as effective as continuous calorie reduction for weight loss in people with obesity. Studies found that IF and similar methods help reduce body weight and body fat, making them viable options for managing obesity. ^{1 2 3 4 5}

Is intermittent fasting safe for humans?

Research shows that intermittent fasting is generally safe for humans, including those with type 2 diabetes and metabolic syndrome, as it does not lead to increased appetite or overeating compared to continuous calorie restriction. ^{1 2 3 4 6}

How is intermittent fasting different from other treatments for prediabetes and obesity?

Intermittent fasting (IF) is unique because it involves restricting food intake to certain periods of the day or extending the fasting interval between meals, unlike continuous calorie reduction which requires consistent daily calorie restriction. This approach can be as effective for weight loss as traditional methods, but it offers flexibility in eating patterns, which some people find easier to maintain. ^{1 2 3 7 8}

Research Team

Pouneh Fazeli, MD

Principal Investigator

University of Pittsburgh

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 have a parent or sibling with type 2 diabetes or a history of gestational diabetes.

I am between 25 and 45 years old.

BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2

Exclusion Criteria

You are currently using drugs or alcohol regularly.

I am on long-term medications or birth control pills.

Pregnant and/or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will fast one day per week for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fasting (Other)

Trial Overview 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.

Participant Groups

Group I: Fasting with weight maintenance Experimental Treatment 2 Interventions

Subjects will fast one-day per week for 12 weeks and maintain body weight

Group II: Fasting Experimental Treatment 1 Intervention

Subjects will fast one-day per week for 12 weeks

Group III: Counseling Placebo Group 1 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 Nearby Select from list below to view details:

UPMC Montefiore Pittsburgh, PA

University of Pittsburgh Pittsburgh, PA

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1820

Patients Recruited

16,360,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2513

Patients Recruited

4,366,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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.

2. Switzerland pubmed.ncbi.nlm.nih.gov

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.

3. United States pubmed.ncbi.nlm.nih.gov

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.

4. Australia pubmed.ncbi.nlm.nih.gov

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)?

5. Canada pubmed.ncbi.nlm.nih.gov

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.

6. United States pubmed.ncbi.nlm.nih.gov

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.

7. Netherlands pubmed.ncbi.nlm.nih.gov

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).

8. Switzerland pubmed.ncbi.nlm.nih.gov

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.