Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. BMI >30 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 (rheumatiod 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 triclyclic antideprssants, some SSRIs, lithium, antipsychotics, some anticonvulsants, steoids, 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
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.

Arm Groups

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

Recruiting Locations

The Rockefeller University Hospital
New York, New York 10065
Contact:
Jeanne M Walker, DNP, NP-BC
212-327-7270
walkerj@rockefeller.edu

More Details

Status
Recruiting
Sponsor
Rockefeller University

Study Contact

Jeanne M Walker, DNP, NP-BC
212-327-7270
walkerj@rockefeller.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.