Time-Restricted Feeding

Obesity Clinical Trial

— TRIO  

Official title:

The Impact of Time-Restricted Feeding on Metabolism and Inflammation in Obesity (TRIO Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884659
• Other study ID #: JAL-1007
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia and inflammation in an inpatient setting.

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 changes in sleeping and eating behaviors has emerged as having a detrimental impact on weight, glucose homeostasis and other cardiovascular disease-related outcomes. Feeding during active periods appears to be advantageous for weight, glucose metabolism and lipid profiles whereas feeding during the inactive period confers deleterious effects on these outcomes. Therefore, TRF shows great promise as a novel intervention for addressing obesity and related cardiovascular outcomes.

Animal studies suggest that timing of feeding, including intermittent fasting or TRF, decreases inflammation and causes ketosis. Human studies that examined time restricted feeding for improvement in glycemia in as little as 4 days did not observe changes in clinical markers of inflammarion such as hsCRP. Moreover, systemic and adipose tissue inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that would not be clearly apparent in a weight stable state. A potential mechanistic link between glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation End-Products (RAGE) and its soluble form (sRAGE).This form of inflammation has not been measured in reported eTRF studies and its relationship with eTRFwould bea significant contribution from the proposed study.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Inflammatory Markers
• Ketosis
• Obesity
• Time Restricted Feeding

Intervention

Other:
• Time restricted feeding arm
80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours
• usual feeding pattern arm
All meals consumed ad lib with 50% of calories consumed after 4PM

Locations

Country	Name	City	State
United States	The Rockefeller University Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

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