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Completed

NCT Number: NCT04884659

Time-Restricted Feeding

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rockefeller University Hospital

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Time restricted feeding arm

Other

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

usual feeding pattern arm

Other

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

Primary outcomes

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

    Time frame: Day 2-Day14

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

    Time frame: Day 2-Day 14

Secondary outcomes

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

    Time frame: Day 2- Day 14

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

    Time frame: Day 2 - Day 14

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

    Time frame: Day 2 - Day 14

  4. changes in gut mirobiome profiles in the TRFarm

    Time frame: Day 2 - Day 14

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

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

Acronym: TRIO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 13, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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