University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05722873
The Metabolic Effects of Intermittent Fasting
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
21 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Fasting arm
BehavioralStudy participants will fast one day per week for 12 weeks
Weight maintenance
BehavioralStudy participants will be counseled to maintain body weight
Counseling
BehavioralStudy participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI
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
Time frame: Baseline, 3 months
Change in insulin sensitivity as assessed by hyperinsulinemic-euglycemic clamp between Baseline and Final Intervention visits
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Pittsburgh
Other
Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Registry information
Official study title
The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
Important dates
- Study start
- 2023
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Feb 10, 2023
- Registry last updated
- May 18, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.