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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how intermittent fasting affects metabolism in individuals with prediabetes or obesity. Researchers aim to determine if fasting benefits, such as better weight control and improved blood pressure, occur without actual weight loss. Participants will either fast one day a week or receive diet and activity advice. Ideal candidates have a BMI between 21 and 29, normal thyroid function, regular menstrual cycles if female, and a family history of type 2 diabetes or gestational diabetes. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on lifestyle interventions.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that intermittent fasting is generally safe. Studies have found that participants often experience health benefits, such as lower blood sugar, improved cholesterol levels, and weight loss.

Most people handle fasting well, though some may feel hungry, tired, or irritable. These feelings are usually mild and subside as the body adjusts. The reviewed studies reported no serious side effects. While fasting might require an adjustment period, it is considered safe for most people to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent fasting for prediabetes and obesity because it offers a unique approach compared to traditional treatments like medication and lifestyle changes focusing solely on diet and exercise. Intermittent fasting involves periodic calorie restriction, which may improve insulin sensitivity and aid in weight loss more effectively than constant dieting. The excitement also stems from its simplicity; fasting one day a week is easier to adopt and maintain for some people compared to more complex dietary regimens. Additionally, there's potential for it to provide metabolic benefits without the need for continuous calorie-counting or dietary restrictions.

What evidence suggests that intermittent fasting could be an effective treatment for prediabetes and obesity?

This trial will compare different approaches to intermittent fasting. Research has shown that intermittent fasting can aid in weight loss and improve the body's sugar processing. It can lower body weight, blood sugar levels, and HbA1c levels, which are crucial for preventing prediabetes from progressing to diabetes. Intermittent fasting might offer similar benefits to traditional calorie-counting diets, but without the need to track every meal. Early studies suggest that fasting may provide health benefits even without weight loss, potentially improving health independently of weight changes. Participants in this trial will either fast one day per week with or without weight maintenance or receive counseling on optimal diet and activity recommendations. ^{2 3 4 5 6}

Who Is on the Research Team?

Pouneh Fazeli, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930668/

Evaluation of the effectiveness of intermittent fasting versus ... IF is a frequently used and effective dietary intervention involving regular periods with no caloric intake. This approach is simple to follow, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04526847

Intermittent Fasting Compared to Continuous Energy ... Studies to date comparing intermittent energy restriction (IER) and continuous energy restriction (CER) have not been investigated on weight loss and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7021351/

Intermittent fasting and weight loss: Systematic review - PMC Intermittent fasting shows promise for the treatment of obesity. To date, the studies have been small and of short duration.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991825000464

Intermittent fasting versus continuous caloric restriction for ... IF shown substantial short-term advantages, encompassing marked decreases in HbA1c levels, fasting glucose, and body weight. Mechanistic discoveries emphasized ...

5. bmj.com bmj.com/content/389/bmj-2024-082007

Intermittent fasting strategies and their effects on body ... The current evidence provides some indication that intermittent fasting diets have similar benefits to continuous energy restriction for weight loss and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9099935/

Intermittent Fasting versus Continuous Calorie Restriction Effects of intermittent versus continuous energy restriction for weight loss on diet quality and eating behavior. A randomized trial. Eur. J ...