Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK133578 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | Experimental | Subjects will fast one-day per week for 12 weeks |
|
| Fasting with weight maintenance | Experimental | Subjects will fast one-day per week for 12 weeks and maintain body weight |
|
| Counseling | Placebo Comparator | Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting arm | Behavioral | Study participants will fast one day per week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride carbon content and degree of saturation | 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 | Baseline, 3 months |
| Trabecular bone microarchitecture | Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Change in insulin sensitivity as assessed by hyperinsulinemic-euglycemic clamp between Baseline and Final Intervention visits | Baseline, 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pouneh Fazeli, MD | Contact | 412-648-9770 | pkfazeli@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pouneh Fazeli, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39299543 | Derived | 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. |
Not provided
Not provided
Deidentified information will be shared upon request.
Beginning 12 months after publication. No end date.
Researchers who wish to access deidentified data.
Not provided
Not provided
| ID | Term |
|---|---|
| D000068959 | Body Weight Maintenance |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D049628 | Body Size |
| D006128 | Growth |
| D048788 | Growth and Development |
Not provided
Not provided
Randomized, controlled study
Not provided
Not provided
Not provided
Not provided
| Weight maintenance | Behavioral | Study participants will be counseled to maintain body weight |
|
| Counseling | Behavioral | Study participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI |
|
| D010829 |
| Physiological Phenomena |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |