Time-Restricted Feeding

NCT04884659 | Completed

• 1 other identifier: JAL-1007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in glycemic variation by mean amplitude of glycemic excursion (MAGE)

  Day 2-Day14

• Change in inflammatory marker concentrations (sRAGE and hsCRP) relative to the UFP arm

  Day 2-Day 14

Secondary Outcomes (4)

• Shift from glucogenic to ketogenic metabolism in the TRF arm relative to the UFP arm by plasma metabolomics

  Day 2- Day 14

• Change in biological indices of appetite (incretins) in TRF arm relative to UFP arm.

  Day 2 - Day 14

• Changes in WBC transcriptomic profiles versus UFP arm between1, 7 and 14 days.

  Day 2 - Day 14

• changes in gut mirobiome profiles in the TRFarm

  Day 2 - Day 14

Study Arms (2)

Timed restricted feeding

EXPERIMENTAL

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.

Other: Time restricted feeding arm; Other: usual feeding pattern arm

Usual feeding pattern

EXPERIMENTAL

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.

Other: Time restricted feeding arm; Other: usual feeding pattern arm

Interventions

Time restricted feeding arm OTHER

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

Timed restricted feeding; Usual feeding pattern

usual feeding pattern arm OTHER

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

Timed restricted feeding; Usual feeding pattern

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Obesity; Intermittent Fasting; Ketosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior; Acidosis; Acid-Base Imbalance; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator and participants will be blinded to randomization prior to initiation of study arm. The randomization will be determined by the research pharmacist. Since the arms require different timing of meals it will be obvious as to the arm, once it is started. However, neither the investigator nor the participant can choose the order of the arms.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 obese, pre-diabetic participants will be randomly assigned to usual eating pattern vs timed restricted eating over 5 days as inpatient in a metabolic unit. They will undergo baseline and post-intervention measurements of glucose tolerance, body compostion by Bod Pod, continuous glucose monitoring by Free-Syle Libre monitor and donate blood for markers of inflammation. They will consume their usual pre-study diet. After completing Arm I, they will cross-over to Arm 2.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: June 10, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)