The Effects of Early and Late Time-Restricted Feeding on Body Composition
1 other identifier
interventional
30
1 country
1
Brief Summary
A randomized controlled trial to determine the effectiveness of either morning or evening time-restricted feeding on body composition in sedentary, breakfast eating overweight and obese adults. Three parallel groups were assigned to either morning fasting (MF), evening fasting (EF), or a control group and asked to do the intervention for 6 weeks. Changes in body composition (change in weight, percent body fat percent, and percent lean body mass) are the primary outcome, and hunger and satiety ratings and physical activity are secondary outcome measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2019
CompletedFirst Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 27, 2019
CompletedJune 27, 2019
June 1, 2019
2 years
June 19, 2019
June 26, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Change in body fat percent
body fat percent at final visit- body fat percent at initial visit
6 weeks
Change in percent lean mass
lean mass percent at final visit - lean mass percent at initial visit
6 weeks
Change in body weight
body weight at final visit - body weight at initial visit
6 weeks
Secondary Outcomes (3)
Change in 24-hour physical activity energy expenditure (PAEE)
change after 3 weeks of intervention
Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 2
Day 2
Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 42
Day 42
Other Outcomes (1)
Compliance with fasting
6 weeks of intervention, daily from start to finish
Study Arms (3)
Control
NO INTERVENTIONThe control group was asked to continue their usual eating schedule and pattern.
Evening Fasters (EF)
EXPERIMENTALEvening fasters were asked to not consume food after 3 pm until the next morning.
Morning Fasters (MF)
EXPERIMENTALMorning fasters were asked to not consume food from the time they woke until 11 am.
Interventions
Restricting the eating window to about 8 hours a day, during waking hours.
Eligibility Criteria
You may qualify if:
- Healthy adults that are currently habitual breakfast eaters, of overweight or obese BMI (BMI 25-35)
You may not qualify if:
- Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
- Currently sedentary.
- Any highly restrictive dietary patterns.
- Currently consumes breakfast at least 5 times per week.
- Weight loss or gain of \>5% of body weight in the past 6 months for any reason except post-partum weight loss.
- Currently taking medication that suppresses or stimulates appetite.
- Currently taking medication that requires eating with food in the morning, including NSAIDs.
- History of prior surgical procedure for weight control or liposuction.
- Current smoker or quit smoking less than 6 months prior.
- Individuals who do resistance training two or more days per week
- Any major disease, including:
- Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
- Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
- Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class \>2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months. Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Active renal disease.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Kinesiology and Sport Managment
Lubbock, Texas, 79409, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily J Dhurandhar, PhD
Texas Tech University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 19, 2019
First Posted
June 27, 2019
Study Start
April 1, 2017
Primary Completion
April 8, 2019
Study Completion
April 8, 2019
Last Updated
June 27, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Within 6 months of publication.
Once the study are accepted for publication, de-identified data will be uploaded to the ICSPR database. The protocol will be shared as supplementary material through the journal where the study if published, if allowed.