The Metabolic Effects of Intermittent Fasting

Conditions

• Normal and Overweight Individuals at High-risk of Diabetes

Eligibility Criteria

Sex

ALL

Age

21 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Oct 25, 2023

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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)

Primary Outcome Measure

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

Central Contacts

• Pouneh Fazeli, MD
  412-648-9770
  [email protected]

Locations (1)

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