Time-Restricted Feeding

NCT ID: NCT04884659

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-08-15

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

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 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.

Conditions

Obesity; Inflammatory Markers; Glycemic Variation; Time Restricted Feeding; Ketosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Timed restricted feeding

Time restricted feeding then usual feeding pattern Day 1, testing

Day 2-7 all meals will be consumed as follows:

80% of calories consumed before 2 PM with remaining 20% consumed by 4PM. Fasting except for water, non caloric drinks for 14-16 hours Same number of calories consumed as in usual feeding pattern arm. Day 8 testing. Day 9-14 crossover to usual feeding pattern arm (meals consumed ad lib with 50% of calories consumed after 4 PM) for 6 days.

Group Type: EXPERIMENTAL

Time restricted feeding arm

Intervention Type: OTHER

80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours

usual feeding pattern arm

Intervention Type: OTHER

All meals consumed ad lib with 50% of calories consumed after 4PM

Usual feeding pattern

Usual feeding pattern, then time restricted feeding Day 1 testing

Day 2-7 all meals will be consumed as follows:

Meals consumed ad lib with 50% of calories consumed after 4 PM. Day 8 testing. Day 9-14 crossover to time restricted feeding arm with all meals consumed as follows:

80% of calories consumed before 2 PM with remaining 20% consumed by 4PM. Fasting except for water, non caloric drinks for 14-16 hours Same number of calories consumed as in usual feeding pattern arm for 6 days.

Group Type: EXPERIMENTAL

Time restricted feeding arm

Intervention Type: OTHER

80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours

usual feeding pattern arm

Intervention Type: OTHER

All meals consumed ad lib with 50% of calories consumed after 4PM

Interventions

Time restricted feeding arm

80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours

Intervention Type: OTHER

usual feeding pattern arm

All meals consumed ad lib with 50% of calories consumed after 4PM

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Rockefeller University Hospital

New York, New York, United States

Countries

United States

Other Identifiers

JAL-1007

Identifier Type: -

Identifier Source: org_study_id