The Metabolic Effects of Intermittent Fasting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fasting arm, Weight maintenance, Counseling.
- Who it may be relevant to
- Registry conditions: Normal and Overweight Individuals at High-risk of Diabetes. Basic parameters: 21 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
Overview
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.
Interventions
- Behavioral Fasting arm
Study participants will fast one day per week for 12 weeks - Behavioral Weight maintenance
Study participants will be counseled to maintain body weight - Behavioral Counseling
Study participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI
Primary outcome measures
- Triglyceride carbon content and degree of saturation [Time frame: Baseline, 3 months]
- Trabecular bone microarchitecture [Time frame: Baseline, 3 months]
Secondary outcome measures (1)
- Insulin sensitivity [Time frame: Baseline, 3 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Publications
- Quaytman JA, David NL, Venugopal S, Amorim T, Beatrice B, Toledo FGS, Miller RG, Steinhauser ML, Fazeli PK. Intermittent fasting for systemic triglyceride metabolic reprogramming (IFAST): Design and methods of a prospective, randomized, controlled trial. Contemp Clin Trials. 2024 Nov;146:107698. doi: 10.1016/j.cct.2024.107698. Epub 2024 Sep 17. PMID 39299543
Identifiers
NCT: NCT05722873 · STUDY21120112 · R01DK133578