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

Time Restricted Feeding Clinical Trial

Official title:

The Effects of Early and Late Time-Restricted Feeding on Body Composition: an Effectiveness Trial in Sedentary Adults With Overweight and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000516
• Other study ID #: IRB2017-99
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: April 8, 2019

Study information

• Verified date: June 2019
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Time Restricted Feeding

Intervention

Behavioral:
• Time restricted feeding
Restricting the eating window to about 8 hours a day, during waking hours.

Locations

Country	Name	City	State
United States	Department of Kinesiology and Sport Managment	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 weeks of intervention, daily from start to finish
Primary	Change in body fat percent	body fat percent at final visit- body fat percent at initial visit	6 weeks
Primary	Change in percent lean mass	lean mass percent at final visit - lean mass percent at initial visit	6 weeks
Primary	Change in body weight	body weight at final visit - body weight at initial visit	6 weeks
Secondary	Change in 24-hour physical activity energy expenditure (PAEE)	PAEE at week 3 of intervention - PAEE at baseline	change after 3 weeks of intervention
Secondary	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	Day 2
Secondary	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	Day 42