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Not Yet Recruiting NCT05722873

The Metabolic Effects of Intermittent Fasting

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

Sex: All
Ages: 25 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: University of Pittsburgh

Location: United States

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 Criteria

Inclusion Criteria:Men and women, ages 25-45 yearsBMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2Normal thyroid functionRegular menses (women)At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetesExclusion Criteria:Any chronic diseases including hypertension and Type 2 diabetes mellitusIndication 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 pillsPregnant and/or breastfeedingHistory of an eating disorder25-OH vitamin D level < 20 ng/mLActive substance abuse, including alcoholSubjects with a prior history of intermittent fastingThe 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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05722873). StuddyBuddy aggregates publicly available trial information.