The Metabolic Effects of Intermittent Fasting

University of Pittsburgh

Status: Enrolling

Conditions: Normal and Overweight Individuals at High-risk of Diabetes

Treatments: Behavioral: Counseling; Behavioral: Fasting arm; Behavioral: Weight maintenance

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05722873

R01DK133578 (U.S. NIH Grant/Contract)

STUDY21120112

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Fasting

Experimental group

Description:

Subjects will fast one-day per week for 12 weeks

Treatment:

Behavioral: Fasting arm

Fasting with weight maintenance

Experimental group

Description:

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

Treatment:

Behavioral: Weight maintenance

Behavioral: Fasting arm

Counseling

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Counseling