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RecruitingNot ApplicableNCT05722873

The Metabolic Effects of Intermittent Fasting

The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism

Sponsor

University of Pittsburgh

Enrollment

90 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Normal and Overweight Individuals at High-risk of Diabetes

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.

Eligibility

Min Age: 21 YearsMax Age: 45 Years

Inclusion Criteria5

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

Exclusion Criteria9

  • Any chronic diseases including hypertension and Type 2 diabetes mellitus
  • 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%)
  • Chronic medications, including oral contraceptive pills
  • Pregnant and/or breastfeeding
  • History of an eating disorder
  • 25-OH vitamin D level < 20 ng/mL
  • Active substance abuse, including alcohol
  • Subjects with a prior history of intermittent fasting
  • 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

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Interventions

BEHAVIORALFasting arm

Study participants will fast one day per week for 12 weeks

BEHAVIORALWeight maintenance

Study participants will be counseled to maintain body weight

BEHAVIORALCounseling

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

Locations(1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT05722873