Aurora, Colorado 80045

  • Obesity

Purpose:

The circadian timing of Energy Intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating later in the evening or at night when the circadian system is promoting sleep adversely influences weight loss. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful weight loss strategy. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators aims are to: 1) Assess processes critical for the success of a large-scale trial comparing the efficacy of a reduced calorie diet with time restricted feeding (RCD+TRF) versus standard RCD on weight loss; 2) Develop methodology to assess compliance to the RCD+TRF versus standard RCD program and collect preliminary data on whether the programs have differential effects on free-living behaviors (EI, appetite, physical activity, and sedentary behavior); and 3) Measure metabolic responses to RCD+TRF versus standard RCD to determine candidate mechanisms related to weight loss at 12wks and weight maintenance at 6mo post-intervention. The investigators primary hypothesis is that weight loss will be greater in the TRF group compared to the RCD group.


Study summary:

The circadian timing of energy intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating meals later in the evening or during the biological night when the circadian system is promoting sleep adversely influences the success of weight loss therapy. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful strategy for promoting weight loss and weight maintenance. However, potential benefits of adding TRF to a weight loss program have yet to be evaluated in a well-controlled clinical study. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators overall hypothesis is that feasibility, adherence, and acceptability of a weight loss intervention using TRF in the setting of a reduced calorie diet (RCD) - RCD+TRF - will be similar to compliance with an intervention using a reduced calorie diet alone (RCD), suggesting acceptability for a future large-scale trial. In this 12-week pilot and feasibility study, 30 overweight and obese individuals will be randomized 1:1 to RCD+TRF (EI restricted to a 10-hour window starting 1 hour from habitual waking time) or standard RCD (no restriction on feeding duration). Additional follow-up will occur at 6 months to collect pilot data on weight maintenance. Measures include feasibility, acceptability and adherence to the interventions, body weight, body composition (Dual-energy X-ray absorptiometry (DXA)), EI (smart phone application), physical activity (PA, accelerometery), glucose variability (continuous glucose monitoring, CGM), sleep (questionnaires and polysomnography), and nocturnal substrate metabolism (room calorimetry). The specific aims (SA) are as follows: Specific Aim 1a. To evaluate the feasibility and acceptability of a 12-week TRF intervention compared to a standard dietary weight loss intervention (i.e. RCD). Feasibility of enrollment and retention, and acceptability of the intervention will be assessed in adults with obesity meeting inclusion/exclusion criteria proposed for the future large-scale trial. The investigators will assess adherence to the weight loss programs, as measured objectively with a novel smartphone application and verified with CGM data, and subjectively with the use of questionnaires. Specific Aim 1b. To assess the efficacy of RCD+TRF compared to RCD alone in producing weight loss at 12 weeks and reducing the risk of weight regain after 6 months of follow-up.


Criteria:

Inclusion Criteria: - Adult males and females with a BMI of 27-45 kg/m2 and weight stable over the previous 6 months; - Age, 18-50 years old; - Passing medical and physical screening, and analysis of blood and urine screening samples; - Typical eating duration >12 hours per day (assessed by questionnaires); - Own a smartphone Exclusion Criteria: - Pregnancy or lactation for women (women who are >6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months) - Postmenopausal women (menopausal status will be assessed during the history and physical, with requirement of self-reported regular menstrual cycles for the last year; women who have undergone hysterectomy but with ovaries in place who continue to have regular menstrual symptoms can be included) - Being considered unsafe to participate as determined by the study physician; - History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism; - History of human immunodeficiency virus or hepatitis B or C (self-report); - Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; - Having abnormal blood chemistry (eGFR<45mL/min, AST or ALT >3 times the upper limit of normal) or as deemed significant by the study physician; - Being a smoker or having been a smoker in the 3 months prior to their screening visit; - Working night shifts; - Extreme early or extreme late chronotype as determined by the Munich Chronotype questionnaire37; - 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) as assessed with meal pattern assessment questionnaire; - For participants completing the PSG studies, greater than moderate sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire). Participants completing the primary weight loss intervention will not be excluded based on Berlin OSA risk scores. - For participants completing the PSG studies, use of medications affecting sleep (benzodiazepines and other sleep aids, as determined by study physician). Participants completing the primary weight loss intervention will not be excluded based on use of medications affecting sleep.


Study is Available At:


Original ID:

18-0487


NCT ID:

NCT03571048


Secondary ID:


Study Acronym:


Brief Title:

Pilot Study of Time Restricted Feeding as a Weight Loss Intervention


Official Title:

Pilot Study of Time Restricted Feeding as a Weight Loss Intervention in Overweight and Obese Adults


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

95


Enrollment Type:

Actual


Overall Contact Information

Official Name:Elizabeth Thomas, MD
Principal Investigator
University of Colorado Anschutz Health and Wellness Center

Study Dates

Start Date:June 1, 2018
Completion Date:November 12, 2020
Completion Type:Actual
Primary Completion Date:May 14, 2020
Primary Completion Type:Actual
Verification Date:February 2021
Last Changed Date:February 8, 2021
First Received Date:May 31, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Changes in Body Weight
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Body weight will be measured via clinic scale.
Outcome Type:Secondary Outcome
Measure:Changes in Body Composition
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Body composition will be assessed with dual-energy x-ray absorptiometry (DXA).
Outcome Type:Secondary Outcome
Measure:Changes in Objectively Measured Energy Intake (Camera)
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:All energy intake events will be recorded using the camera function on a cell phone application
Outcome Type:Secondary Outcome
Measure:Changes in Objectively Measured Meal Timing (Camera)
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Time stamps of all energy intake events will be recorded using the camera function on a cell phone application
Outcome Type:Secondary Outcome
Measure:Changes in Resting Energy Expenditure (REE)
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:REE will be measured using indirect calorimetry.
Outcome Type:Secondary Outcome
Measure:Changes in Physical Activity
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Physical activity will be measured with activity monitors.
Outcome Type:Secondary Outcome
Measure:Changes in Sedentary Behavior
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Sedentary behavior will be measured with activity monitors.
Outcome Type:Secondary Outcome
Measure:Changes in daily glucose patterns
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Measured using continuous glucose monitors
Outcome Type:Secondary Outcome
Measure:Changes in free-living sleep patterns
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Sleep will be assessed by wrist actigraphy
Outcome Type:Secondary Outcome
Measure:Changes in Self-Reported Dietary Adherence
Time Frame:Baseline and weeks 4, 8, 12
Safety Issues:False
Description:Adherence to prescribed diet will be assessed with a questionnaire.
Outcome Type:Secondary Outcome
Measure:Changes in appetite
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Appetite will be assessed with a Visual Analog Scale (VAS) questionnaire.
Outcome Type:Secondary Outcome
Measure:Changes in mood
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Mood will be assessed with questionnaires.
Outcome Type:Secondary Outcome
Measure:Changes in quality of life
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Quality of life will be assessed with questionnaires.
Outcome Type:Secondary Outcome
Measure:Objective measures of nocturnal energy expenditure
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Nocturnal energy expenditure will be measured by room calorimetry
Outcome Type:Secondary Outcome
Measure:Objective measures of sleep
Time Frame:Baseline, 12 weeks
Safety Issues:False
Description:Sleep will be measured in the laboratory by polysomnography

Study Interventions

Intervention Type:Behavioral
Name:Time Restricted Feeding (TRF)
Description:Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distractio
Arm Name:Time Restricted Feeding (TRF)
Intervention Type:Behavioral
Name:Reduced Calorie Diet (RCD)
Description:Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Arm Name:Reduced Calorie Diet (RCD)

Study Arms

Study Arm Type:Experimental
Arm Name:Time Restricted Feeding (TRF)
Description:Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Study Arm Type:Active Comparator
Arm Name:Reduced Calorie Diet (RCD)
Description:Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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