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ObesityNCT03459703

Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults

A study testing Early Time-Restricted Feeding and Structured Weight Loss Program in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Read more about this study

Who is it for?
Ages 25 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Early Time-Restricted Feeding and Structured Weight Loss Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
12 Jul 2018to 30 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are a new patient at the UAB Weight Loss Medicine Clinic
  • Aged 25-75 years old
  • BMI between 30-60 kg/m2 (inclusive)
  • Weigh less than 450 lbs
  • Wake up regularly between 4-9 am on most days.

Who cannot join

  • Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
  • On weight loss medication
  • Addition of or withdrawal from a chronic medication within the past 10 weeks
  • Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
  • Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
  • Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
Show all 15Show fewer
  • Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
  • Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
  • Lost or gained more than 5 lbs of weight in the past month
  • Currently perform overnight shift work more than once per week on average
  • Regularly eat within a less than 10-hour period each day
  • Regularly eat dinner before 6 pm
  • Traveled more than two time zones away in the two months prior to enrolling in the trial
  • Will travel more than one time zone away during the study
  • Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UAB Weight Loss Medicine Clinic

    Birmingham, Alabama, 35205

Other trials in United States

About this study

Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF.

In conjunction with the parent study described above, four ancillary studies will be conducted:

  1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance.
  2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine.
  3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour bins to determine how meal timing affects differentially affects these endpoints during the daytime and nighttime. The effects of weight loss on these endpoints may also be considered.
  4. Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.
Conditions
Obesity
Being tested
Early Time-Restricted Feeding, Control Schedule, Structured Weight Loss Program
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Time-Restricted FeedingBehavioural

    Also called Early TRF, eTRF

    Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.

  • Control ScheduleBehavioural

    Eat all meals over a 12-hour or longer period for an average of ≥6 days per week.

  • Structured Weight Loss ProgramBehavioural

    A structured weight loss program with physical activity recommendations and dietary counseling.

Study groups in NCT03459703
Study groupRoleWhat they receive
Early Time-Restricted FeedingExperimentalNot described
Receives: Behavioral: Early Time-Restricted Feeding; Behavioral: Structured Weight Loss Program
Control ScheduleActive comparatorNot described
Receives: Behavioral: Control Schedule; Behavioral: Structured Weight Loss Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat loss and lean mass retention

    Percent of weight lost as fat, as measured by dual-energy X-ray absorptiometry (DXA). Lean mass retention will be quantified as 100% minus percent of weight lost as fat (i.e., is measured in the same units).

    Measured: 14 weeks

  2. Weight loss

    Change in body weight (kg), as measured by scale weight

    Measured: 14 weeks

  3. Absolute changes in body composition

    Changes in total fat mass, lean mass, bone mass, and regional values (kg), as measured by DXA. (This will be secondary to the assessment of fat loss and lean mass retention as specified above.)

    Measured: 14 weeks

Secondary outcomes (7)

  1. Fasting glucose

    Fasting glucose (mg/dl)

    Measured: 14 weeks

  2. Fasting insulin

    Fasting insulin (IU/L)

    Measured: 14 weeks

  3. HbA1c

    HbA1c (%)

    Measured: 14 weeks

  4. Lipids

    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)

    Measured: 14 weeks

  5. Blood pressure

    Systolic and diastolic blood pressure (mm Hg)

    Measured: 14 weeks

  6. Heart rate

    Heart rate in beats per minute

    Measured: 14 weeks

  7. Waist circumference

    Waist circumference (cm)

    Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2018
  2. Study start12 Jul 2018
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459703
Sponsor's protocol ID
IRB-300001207
Status last verified
Jul 2020
First submitted
14 Feb 2018
Last updated
8 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rehman Z, Altonji OM, Steger FL, Jamshed H, Richman JS, Warriner AH, Peterson CM. Do the Effects of Early Time-Restricted Eating Vary by Cardiometabolic Phenotype, Age, Sex, or Race? A Secondary Analysis of a Randomized Controlled Trial. J Nutr. 2026 Jun;156(6):101526. doi: 10.1016/j.tjnut.2026.101526. Epub 2026 Apr 5.

    PubMed 41941962

  • Jamshed H, Steger FL, Bryan DR, Richman JS, Warriner AH, Hanick CJ, Martin CK, Salvy SJ, Peterson CM. Effectiveness of Early Time-Restricted Eating for Weight Loss, Fat Loss, and Cardiometabolic Health in Adults With Obesity: A Randomized Clinical Trial. JAMA Intern Med. 2022 Sep 1;182(9):953-962. doi: 10.1001/jamainternmed.2022.3050.

    PubMed 35939311

  • 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.

    PubMed 33512717

Questions about this trial

What is this clinical trial studying?

A study testing Early Time-Restricted Feeding and Structured Weight Loss Program in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat loss and lean mass retention (time frame: 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459703, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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