The Metabolic Effects of Intermittent Fasting

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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:

🦠 Normal and Overweight Individuals at High-risk of Diabetes

🗓️ Study Start (Actual) 25 October 2023

🗓️ Primary Completion (Estimated) June 2028

✅ Study Completion (Estimated) June 2028

👥 Enrollment (Estimated) 90

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. Men and women, ages 25-45 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

Ages Eligible for Study: 25 Years to 45 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 27 January 2023
First Submitted that Met QC Criteria 1 February 2023
First Posted 10 February 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 1 March 2024
Last Update Posted 4 March 2024
Last Verified March 2024