CClinicalTrials.gg
CompletedNCT04000516Updated Jun 27, 2019

The Effects of Early and Late Time-Restricted Feeding on Body Composition

An interventional study of Time restricted feeding in Time Restricted Feeding, sponsored by Texas Tech University. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by Texas Tech University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Apr 2017, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Time Restricted Feeding
03

In context

Lead sponsor

Texas Tech University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults that are currently habitual breakfast eaters, of overweight or obese BMI (BMI 25-35)

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Lung disease: chronic obstructive airway disease requiring use of oxygen.
  • Diagnosed diabetes (type 1 or 2) .
  • Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
  • Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
  • Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months.
  • A recent or ongoing problem with drug abuse or addiction.
  • Excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.
  • Working the "night shift" or any work schedule that would interfere with normal eating patterns.
  • Not willing to be randomized to any of the three experimental conditions.
  • Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take Qualtrics Screening Survey adequate contraceptive measures if potentially fertile.
  • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Control

    The control group was asked to continue their usual eating schedule and pattern.

  • Experimental
    Evening Fasters (EF)

    Evening fasters were asked to not consume food after 3 pm until the next morning.

    Behavioral: Time restricted feeding

  • Experimental
    Morning Fasters (MF)

    Morning fasters were asked to not consume food from the time they woke until 11 am.

    Behavioral: Time restricted feeding

Interventions

  • BehavioralTime restricted feeding

    Restricting the eating window to about 8 hours a day, during waking hours.

06

What researchers measure

Primary outcomes

  1. Change in body fat percent

    body fat percent at final visit- body fat percent at initial visit

    Time frame: 6 weeks

  2. Change in percent lean mass

    lean mass percent at final visit - lean mass percent at initial visit

    Time frame: 6 weeks

  3. Change in body weight

    body weight at final visit - body weight at initial visit

    Time frame: 6 weeks

Secondary outcomes

  1. Change in 24-hour physical activity energy expenditure (PAEE)

    PAEE at week 3 of intervention - PAEE at baseline

    Time frame: change after 3 weeks of intervention

  2. Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 2

    Hunger on day 2 of fasting pattern just before breaking fast, compared to hunger at that time in control group

    Time frame: Day 2

  3. Hunger measured by Visual Analog Scale (How Hungry do you feel now?) before breaking fast Day 42

    Hunger on Day 42 of fasting pattern just before breaking fast, compared to hunger at that time in control group

    Time frame: Day 42

Other outcomes

  1. Compliance with fasting

    Percent of days during entire 6-week trial when fasting pattern was adhered to as recommended, recorded daily through the entire study.

    Time frame: 6 weeks of intervention, daily from start to finish

07

Study locations

1 site
  • Department of Kinesiology and Sport Managment
    Lubbock, Texas 79409, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04000516
Lead sponsor
Texas Tech University
Responsible party
Emily Dhurandhar (Assistant Professor, Texas Tech University) — Principal investigator
First posted
Jun 27, 2019
Start date
Apr 1, 2017
Primary completion
Apr 8, 2019
Completion
Apr 8, 2019
Last update
Jun 27, 2019

Study contacts

Emily J Dhurandhar, PhD
principal investigator · Texas Tech University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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