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

NCT03459703 | Completed

• 1 other identifier: IRB-300001207
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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. 4.Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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).

  14 weeks

• Weight loss

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

  14 weeks

• 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.)

  14 weeks

Secondary Outcomes (7)

• Fasting glucose

  14 weeks

• Fasting insulin

  14 weeks

• HbA1c

  14 weeks

• Lipids

  14 weeks

• Blood pressure

  14 weeks

Other Outcomes (38)

• Appetite

  14 weeks

• Food intake

  14 weeks

• Macronutrient intake

  14 weeks

Study Arms (2)

Early Time-Restricted Feeding

EXPERIMENTAL

Behavioral: Early Time-Restricted Feeding; Behavioral: Structured Weight Loss Program

Control Schedule

ACTIVE COMPARATOR

Behavioral: Control Schedule; Behavioral: Structured Weight Loss Program

Interventions

Early Time-Restricted Feeding BEHAVIORAL

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

Also known as: Early TRF, eTRF

Early Time-Restricted Feeding

Control Schedule BEHAVIORAL

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

Control Schedule

Structured Weight Loss Program BEHAVIORAL

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

Control Schedule; Early Time-Restricted Feeding

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Weight Loss Medicine Clinic

Birmingham, Alabama, 35205, United States

Location

Related Publications (2)

• 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.

  PMID: 35939311 DERIVED

• 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: 33512717 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Courtney M Peterson, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analyses will be performed blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 9, 2018
• Study Start: July 12, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

US (1)