Actively Recruiting

Phase Not Applicable
Age: 21Years - 45Years
All Genders
Healthy Volunteers
NCT05722873

The Metabolic Effects of Intermittent Fasting

Led by University of Pittsburgh · Updated on 2025-08-07

90

Participants Needed

1

Research Sites

244 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

The Metabolic Effects of Intermittent Fasting

Who Can Participate

Age: 21Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women, ages 21 to 45 years
  • BMI between 21 and 29 kg/m2
  • Normal thyroid function
  • Regular menstrual cycles (women)
  • At least one first-degree relative with type 2 diabetes or history of gestational diabetes
Not Eligible

You will not qualify if you...

  • Presence of chronic diseases including hypertension and type 2 diabetes
  • Need for lipid-lowering therapy per AHA guidelines (LDL >190 or 10-year ASCVD risk >7.5%)
  • Use of chronic medications, including oral contraceptive pills
  • Pregnancy or breastfeeding
  • History of an eating disorder
  • Vitamin D level below 20 ng/mL
  • Active substance abuse, including alcohol
  • Prior history of intermittent fasting
  • Considered by study physician as unable to safely complete the protocol or at risk by participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

P

Pouneh Fazeli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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