Recruiting

Intermittent Fasting

Sponsor:

University of Pittsburgh

Code:

NCT05722873

Conditions

Normal and Overweight Individuals at High-risk of Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Accepted

Interventions

Fasting arm

Weight maintenance

Counseling

Study Details

Brief summary:

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.

Conditions

Normal and Overweight Individuals at High-risk of Diabetes

Study ID

NCT05722873

Start date

Oct 25, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Men and women, ages 21-45 years
2. BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
3. Normal thyroid function
4. Regular menses (women)
5. At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes

Exclusion Criteria:

1. Any chronic diseases including hypertension and Type 2 diabetes mellitus
2. Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL>190 or an estimated 10-year ASCVD risk of >7.5%)
3. Chronic medications, including oral contraceptive pills
4. Pregnant and/or breastfeeding
5. History of an eating disorder
6. 25-OH vitamin D level < 20 ng/mL
7. Active substance abuse, including alcohol
8. Subjects with a prior history of intermittent fasting
9. The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Fasting

Subjects will fast one-day per week for 12 weeks

experimental: Fasting with weight maintenance

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

placebo comparator: Counseling

Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)

Interventions

Fasting arm

Study participants will fast one day per week for 12 weeks

Weight maintenance

Study participants will be counseled to maintain body weight

Counseling

Study participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI

Primary outcome measure

  • Triglyceride carbon content and degree of saturation [ Time Frame: Baseline, 3 months ]
  • Trabecular bone microarchitecture [ Time Frame: Baseline, 3 months ]

Central Contacts and Locations

Central contacts

Pouneh Fazeli, MD

412-648-9770pkfazeli@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Pouneh Fazeli, MD

pkfazeli@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-18.