The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Triglyceride carbon content and degree of saturation
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Fasting with weight maintenance
Subjects will fast one-day per week for 12 weeks and maintain body weight
Intervention: Fasting arm (Behavioral)
Fasting with weight maintenance
Subjects will fast one-day per week for 12 weeks and maintain body weight
Intervention: Weight maintenance (Behavioral)
Fasting
Subjects will fast one-day per week for 12 weeks
Intervention: Fasting arm (Behavioral)
Counseling
Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)
Intervention: Counseling (Behavioral)
Outcomes
Primary Outcomes
Triglyceride carbon content and degree of saturation
Time Frame: Baseline, 3 months
Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits
Trabecular bone microarchitecture
Time Frame: Baseline, 3 months
Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits
Secondary Outcomes
- Insulin sensitivity(Baseline, 3 months)
Investigators
Pouneh K. Fazeli, MD
Associate Professor of Medicine
University of Pittsburgh