Clinical trial

The Metabolic Effects of Intermittent Fasting

Recruiting now · Not applicable · 1 countries · Registry ID NCT05722873

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 45 Years

SexAll

Healthy volunteersAccepted

ConditionNormal and Overweight Individuals at High-risk of Diabetes

Full registry criteria

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

Treatments and study arms

Fasting arm

Behavioral

Study participants will fast one day per week for 12 weeks

Weight maintenance

Behavioral

Study participants will be counseled to maintain body weight

Counseling

Behavioral

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

Primary outcomes

Triglyceride carbon content and degree of saturationBaseline, 3 months

Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits

Trabecular bone microarchitectureBaseline, 3 months

Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Pittsburgh🇺🇸 Pittsburgh, Pennsylvania, United States

Open map

Pouneh Fazeli, MDContact