Exploring the metabolic effects of intermittent fasting
The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
NA · University of Pittsburgh · NCT05722873
This study tests if intermittent fasting can improve health markers like blood pressure and cholesterol in people at high risk for diabetes, regardless of whether they lose weight.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05722873 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic effects of intermittent fasting in normal and overweight individuals who are at high risk for diabetes. It aims to determine whether the benefits of fasting, such as improvements in blood pressure and lipid levels, are independent of weight loss. Participants will be assigned to a fasting arm, weight maintenance, or counseling to assess these effects. The study will also evaluate any potential negative impacts on bone metabolism associated with fasting.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 25-45 with a BMI between 21 and 29, normal thyroid function, and a family history of type 2 diabetes.
Not a fit: Patients with chronic diseases, including hypertension and type 2 diabetes, or those with a history of eating disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into alternative dietary approaches that improve metabolic health without the need for continuous caloric restriction.
How similar studies have performed: While intermittent fasting has gained popularity, this specific approach to evaluating its metabolic effects independent of weight loss is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Pouneh Fazeli, MD — University of Pittsburgh
- Study coordinator: Pouneh Fazeli, MD
- Email: pkfazeli@pitt.edu
- Phone: 412-648-9770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Normal and Overweight Individuals at High-risk of Diabetes