NCT04009239

Brief Summary

Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of meal intake relative to the light-dark and sleep-wake cycle is rarely considered in metabolic health; and modifying meal timing is likely easier to implement in daily life than reducing caloric intake and/or increasing physical activity. This project will test whether restricting the timing of energy intake to a short-defined period during wakefulness can be used to improve fuel utilization patterns and enhance circadian rhythms in metabolic tissues to optimize health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

3.2 years

First QC Date

June 27, 2019

Last Update Submit

July 12, 2022

Conditions

ObesityDiabetes

Keywords

Weight lossDiet

Outcome Measures

Primary Outcomes (6)

  • Total fat oxidation in response to eTRF

    Total fat oxidation will measured by whole room calorimetry. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.

    Week 1 or Week 5

  • Total fat oxidation in response to mTRF

    Total fat oxidation will measured by whole room calorimetry. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.

    Week 1 or Week 5

  • Insulin sensitivity in response to eTRF

    Insulin sensitivity measured by three identical mixed meal tolerance tests administered across the day. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.

    Week 1 or Week 5

  • Insulin sensitivity in response to mTRF

    Insulin sensitivity measured by three identical mixed meal tolerance tests administered across the day. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.

    Week 1 or Week 5

  • Glucose control in response to eTRF

    Glucose control will be measured by a continuous glucose monitor. Mid-day Time Restricted Feeding (mTRF) may occur at Week 1 or Week 5 depending on randomization.

    Week 1 or Week 5

  • Glucose control in response to mTRF

    Glucose control will be measured by a continuous glucose monitor. Early Time Restricted Feeding (eTRF) may occur at Week 1 or Week 5 depending on randomization.

    Week 1 or Week 5

Secondary Outcomes (9)

  • Difference in dietary fat oxidation between experimental conditions

    Week 1 and Week 5

  • Difference in 24h energy expenditure between experimental conditions

    Week 1 and Week 5

  • Difference in sleep between experimental conditions

    Week 1 and Week 5

  • Difference in the melatonin rhythm between experimental conditions

    Week 1 and Week 5

  • Difference in plasma metabolite rhythms between experimental conditions

    Week 1 and Week 5

  • +4 more secondary outcomes

Study Arms (2)

Early Time Restricted Feeding

EXPERIMENTAL

Consume meals for 7 days during an 8 hour window starting 1 hour after habitual wake time.

Behavioral: Time Restricted Feeding

Mid-day Time Restricted Feeding

EXPERIMENTAL

Consume meals for 7 days during an 8 hour window starting 6 hours after habitual wake time.

Behavioral: Time Restricted Feeding

Interventions

Time Restricted FeedingBEHAVIORAL

Consuming energy during a short interval during the day

Early Time Restricted FeedingMid-day Time Restricted Feeding

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women with overweight and class I obesity (N=12, Age=20-50 years; BMI 25-35 kg/m2)
  • Low physical activity level (≤150 min/wk of moderate-to-vigorous activity);
  • For Females- Not currently pregnant or lactating and not pregnant within the past 6 months
  • Habitually consume food over a window of \>12 h/day;
  • Pass a medical and physical screening performed by the study physician.
  • Report a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100h and getting up between 0600 and 0900 h with \>7 h and \<9.25 h in bed;
  • Agree to eat control diets at imposed times for 1 week prior to the inpatient CTRC visits;
  • Agree to keep a regular sleep/wake schedule for the duration of the study
  • Possess a smart phone to install and utilize the meal timing application.

You may not qualify if:

  • Subjects must not be currently participating in another research study that would influence their safe participation in this study. For example, subjects must not be participating in a research study in which they ingest experimental medication, or which involves blood samples, since both of these factors could increase risk of participation;
  • Being considered unsafe to participate as determined by the study physician;
  • Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months;
  • Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
  • o Have one or more of the following out-of-range values measured on a fasting blood sample: glucose \> 126 mg/dl, HbA1c \> 6.5%, thyroid stimulating hormone \<0.5 or \>5.0 uU/ml. Subjects who may be anemic (hemoglobin \<14.5 g/dl men, \<12.3 g/dl women), have abnormal liver function tests (alanine amino transferase \> 47 U/l, aspartate aminotransferase, \> 47 U/l, alkaline phosphatase \<39 or \>117 U/l) or creatinine (\>1.1 mg/dl)
  • Significant abnormality in clinical laboratory values
  • Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
  • History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
  • Score \> 18 on Beck Depression Index (BDI) will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
  • Use of a continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea (OSA). A score of \>10 on the Epworth sleepiness scale or \>5 on the Pittsburgh Sleep Quality Index will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
  • Being positive for human immunodeficiency virus or hepatitis B or C;
  • Being a smoker or having been a smoker in the previous 6 months;
  • Abnormal eating patterns identified by registered dietician interview (dietary fat\<15%, dietary fat\>45%, dietary protein \>30%);
  • Working night shifts;
  • Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

MeSH Terms

Conditions

ObesityDiabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Corey A Rynders, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 5, 2019

Study Start

January 15, 2019

Primary Completion

April 8, 2022

Study Completion

April 8, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)