Intermittent Fasting for Prediabetes and Obesity

Recruiting at 1 trial location

Overseen By Pouneh Fazeli, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Chronic medications

Disqualifiers: Hypertension, Type 2 diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

90 Participants Needed

Trial Summary

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}

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.

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

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

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)

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Intermittent fasting (IF) and continuous energy-restricted diets (CERD) showed similar effects on glycemic control in patients with type 2 diabetes and metabolic syndrome, based on a meta-analysis of four studies with 355 participants.

However, IF resulted in greater weight loss compared to CERD, indicating it may be a beneficial dietary approach for overweight or obese patients with these conditions.

NCBI (Pubmed)

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. Wang, X., Li, Q., Liu, Y., et al.[2021]

Intermittent energy restriction (IER) strategies, such as intermittent fasting and time-restricted feeding, show similar effectiveness in weight loss compared to continuous energy restriction (CER) in adults with obesity, based on a review of randomized trials lasting at least 8 weeks.

Out of 11 studies analyzed, 9 found no significant differences in weight or body fat loss between IER and CER, suggesting that IER can be a viable alternative for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Rynders, CA., Thomas, EA., Zaman, A., et al.[2021]

Intermittent energy restriction (IER) was found to be a feasible and effective weight management strategy for adolescents aged 12-17 with obesity, leading to a significant reduction in BMI %95th percentile after 12 weeks (-5.6%) and maintained reductions at 26 weeks.

Participants reported IER as easy and pleasant to follow, indicating high acceptability, and the intervention also resulted in improvements in cardiovascular health markers, such as reduced carotid intima-media thickness and improved flow-mediated dilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. Jebeile, H., Gow, ML., Lister, NB., et al.[2023]

Intermittent fasting (IF) may be an effective weight management strategy for overweight and obese adults, but its evidence base in humans is still limited, with only one published systematic review available.

Current guidelines from the National Institute for Health and Care Excellence (NICE) do not recommend very low calorie diets (VLCD) as a routine treatment for obesity, highlighting concerns about potential side effects and the sustainability of fasting approaches.

NCBI (Pubmed)

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. Jane, L., Atkinson, G., Jaime, V., et al.[2022]

Intermittent fasting (IF) has been shown to result in weight loss ranging from 0.8% to 13.0% of baseline weight across 27 trials, with no serious adverse events reported, indicating it is a safe option for treating obesity.

When compared to traditional calorie-restricted diets, IF produced equivalent weight loss results, and it also improved glycemic control in patients with type 2 diabetes, suggesting its potential effectiveness in managing obesity and related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting and weight loss: Systematic review. Welton, S., Minty, R., O'Driscoll, T., et al.[2021]

In a study involving 46 women with overweight/obesity, both continuous energy restriction (CER) and intermittent energy restriction (IER) led to similar weight loss of at least 5% without significant differences in body composition or appetite changes.

Both weight loss strategies improved eating behavior traits, such as dietary restraint and craving control, indicating that neither approach resulted in compensatory increases in appetite or overeating.

NCBI (Pubmed)

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. Beaulieu, K., Casanova, N., Oustric, P., et al.[2023]

This study is a randomized trial involving 186 adolescents aged 13-17 with obesity, comparing the effects of intermittent energy restriction (IER) and continuous energy restriction (CER) on BMI z-scores over 52 weeks.

The research aims to determine if IER, which includes alternating days of low-calorie intake, can be as effective or more effective than the standard CER approach for weight management in adolescents with metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol. Lister, NB., Jebeile, H., Truby, H., et al.[2021]

A 4-week study involving 48 overweight/obese adults showed that intermittent energy restriction (IER) led to a greater average weight loss of 4.57 kg compared to 2.46 kg with continuous energy restriction (CER), indicating IER may be more effective for weight loss when combined with high-intensity interval training (HIIT).

Both IER and CER resulted in improvements in body composition and cardiorespiratory fitness (CRF), but IER showed superior benefits in reducing body fat percentage and waist circumference compared to CER, suggesting it may be a more advantageous dietary approach.

NCBI (Pubmed)

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. Xu, R., Cao, YX., Chen, YT., et al.[2022]

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]

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

Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. [2021]

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

Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. [2023]

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]

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

Intermittent fasting and weight loss: Systematic review. [2021]

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]

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]

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]