Status:
COMPLETED
Time-Restricted Feeding
Lead Sponsor:
Rockefeller University
Conditions:
Obesity
Inflammatory Markers
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Time Restricted Feeding (TRF) is a variant of intermittent fasting that confines caloric intake to active daytime hours and involves fasting for 12 to 14 hours. Circadian misalignment caused by change...
Eligibility Criteria
Inclusion
- BMI \>25 kg/m2
- If taking probiotics during screening, must agree to continue taking them at the same dosage and frequency
- HbA1C 5.7-6.4%
- Willing to eat only the food provided
- Willing to follow the feeding schedule, including fasting for 14 hours/day for 7 days
- Willing to remain on the RU inpatient 24/7 unit except for weekend passes
- Normally sleep between the hours of 10 pm and 8 am
- Weight stable over the last 3 months defined as no more than a 5% change
Exclusion
- Diabetes
- Any intermittent feeding diet within the last 2 weeks
- HIV positive
- Hepatitis
- Self-reported autoimmune diseases (rheumatoid arthritis, SLE (lupus), Crohn's
- Disease, psoriasis, etc.)
- Current use of metformin
- Smoked tobacco within the last 8 weeks
- Taking any weight loss medication
- Current use of systemic steroids
- Allergic to adhesive tape
- 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.
- Currently pregnant
- 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
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04884659
Start Date
June 10 2021
End Date
August 15 2022
Last Update
August 24 2022
Active Locations (1)
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1
The Rockefeller University Hospital
New York, New York, United States, 10065