Obesity Clinical Trial
— TRIOOfficial title:
The Impact of Time-Restricted Feeding on Metabolism and Inflammation in Obesity (TRIO Study)
NCT number | NCT04884659 |
Other study ID # | JAL-1007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2021 |
Est. completion date | August 15, 2022 |
Verified date | August 2022 |
Source | Rockefeller University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity. We will study the effect of restricting the timing of caloric intake to earlier in the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia and inflammation in an inpatient setting.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 15, 2022 |
Est. primary completion date | August 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. BMI >25 kg/m2 2. If taking probiotics during screening, must agree to continue taking them at the same dosage and frequency 3. HbA1C 5.7-6.4% 4. Willing to eat only the food provided 5. Willing to follow the feeding schedule, including fasting for 14 hours/day for 7 days 6. Willing to remain on the RU inpatient 24/7 unit except for weekend passes 7. Normally sleep between the hours of 10 pm and 8 am 8. Weight stable over the last 3 months defined as no more than a 5% change Exclusion Criteria: 1. Diabetes 2. Any intermittent feeding diet within the last 2 weeks 3. HIV positive 4. Hepatitis 5. Self-reported autoimmune diseases (rheumatoid arthritis, SLE (lupus), Crohn's 6. Disease, psoriasis, etc.) 7. Current use of metformin 8. Smoked tobacco within the last 8 weeks 9. Taking any weight loss medication 10. Current use of systemic steroids 11. Allergic to adhesive tape 12. Taking clinically useful medications that contribute to significant weight loss or weight gain ie tricyclic antidepressants, some SSRIs, lithium, antipsychotics, some anticonvulsants, steroids, beta blockers, some antihistamines. 13. Currently pregnant 14. Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data |
Country | Name | City | State |
---|---|---|---|
United States | The Rockefeller University Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Rockefeller University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in glycemic variation by mean amplitude of glycemic excursion (MAGE) | Day 2-Day14 | ||
Primary | Change in inflammatory marker concentrations (sRAGE and hsCRP) relative to the UFP arm | Day 2-Day 14 | ||
Secondary | Shift from glucogenic to ketogenic metabolism in the TRF arm relative to the UFP arm by plasma metabolomics | Day 2- Day 14 | ||
Secondary | Change in biological indices of appetite (incretins) in TRF arm relative to UFP arm. | Day 2 - Day 14 | ||
Secondary | Changes in WBC transcriptomic profiles versus UFP arm between1, 7 and 14 days. | Day 2 - Day 14 | ||
Secondary | changes in gut mirobiome profiles in the TRFarm | Day 2 - Day 14 |
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