The Metabolic Effects of Intermittent Fasting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Normal and Overweight Individuals at High-risk of Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fasting

Subjects will fast one-day per week for 12 weeks

Group Type EXPERIMENTAL

Fasting arm

Intervention Type BEHAVIORAL

Study participants will fast one day per week for 12 weeks

Fasting with weight maintenance

Subjects will fast one-day per week for 12 weeks and maintain body weight

Group Type EXPERIMENTAL

Fasting arm

Intervention Type BEHAVIORAL

Study participants will fast one day per week for 12 weeks

Weight maintenance

Intervention Type BEHAVIORAL

Study participants will be counseled to maintain body weight

Counseling

Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)

Group Type PLACEBO_COMPARATOR

Counseling

Intervention Type BEHAVIORAL

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

Interventions

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Fasting arm

Study participants will fast one day per week for 12 weeks

Intervention Type BEHAVIORAL

Weight maintenance

Study participants will be counseled to maintain body weight

Intervention Type BEHAVIORAL

Counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Men and women, ages 21-45 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes