Exercise Training and Time-restricted Feeding in Overweight and Obese Adults

NCT03823872 | Completed DMC

• 1 other identifier: HE18247
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Overweight and obesity prevalence in adolescents and adults continues to remain significantly high in the United States. While diet and exercise improve many consequences of obesity, dietary strategies are not always nutrient sufficient and manageable long-term. Thus, highly complaint dietary strategies that lead to fat loss, while maintaining muscle mass, are needed. Time-restricted feeding (TRF) may be an ideal dietary approach for reducing fat mass and cardiovascular disease risk, while diminishing the loss of muscle mass and strength associated with obesity and aging. TRF, unlike continuous energy restriction, does not require a restrictive energy intake10. TRF requires individuals to consume calories within a set window of time (example = 8 hours), inducing a fasting window of 16 hours per day. There are few human studies on TRF that measure their effects in combination with both aerobic and resistance training. One recent study found an 8-hour TRF program (16-hour fast) improved insulin sensitivity, decreased fat mass, and maintained muscle mass in resistance-trained males after 8 weeks. Thus, the feasibility of TRF as dietary approach should be investigated further.The aims of this study are to: 1) determine whether time-restricted feeding (TRF) is an effective dietary strategy for reducing fat mass while preserving fat-free mass with aerobic and resistance training; 2) evaluate potential changes in health-related biomarkers (cardiovascular profile and anabolic-catabolic hormones) and muscle health indicators (mass, strength and quality) after 8 weeks of concurrent training with TRF; and 3) examine the influence of caloric intake and macronutrient consumption on muscle health in the TRF and normal feeding (NF) groups pre- to post-concurrent resistance training.

Conditions

Overweight and Obesity; Weight Loss

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Body mass after 8 weeks

  mass kg of subject on a calibrated scale

  change from 8 weeks

• Change from Baseline fat mass after 8 weeks

  fat mass in kg of the subject measured by DXA

  change from 8 weeks

• Change from Baseline lean mass after 8 weeks

  lean mass kg of the subject measured by DXA

  change from 8 weeks

Secondary Outcomes (14)

• Change from Baseline insulin after 8 weeks

  change from 8 weeks

• Change from Baseline high-sensitivity C-reactive protein (Hs-CRP) after 8 weeks

  change from 8 weeks

• Change from Baseline hemoglobin A1c after 8 weeks

  change from 8 weeks

• Change from Baseline triglycerides after 8 weeks

  change from 8 weeks

• Change from Baseline cholesterol 8 weeks

  change from 8 weeks

Study Arms (2)

Overweight

EXPERIMENTAL

Participants with BMI 25-29.9 kg/m2 undergo structured exercise for weight loss. They are randomized to the following interventions: 1) time restricted feeding = only eat between 12pm-8pm or 2) normal feeding= eat on normal schedule.

Other: Time restricted feeding; Other: Normal feeding

Obese

EXPERIMENTAL

Participants with BMI 29.9-34.9 kg/m2 undergo structured exercise for weight loss. They are randomized to the following interventions: 1) time restricted feeding = only eat between 12pm-8pm or 2) normal feeding= eat on normal schedule.

Other: Time restricted feeding; Other: Normal feeding

Interventions

Time restricted feeding OTHER

Time restricted feeding= consume food only from 12:00pm-8:00pm

Obese; Overweight

Normal feeding OTHER

Normal feeding= consume food per normal schedule

Obese; Overweight

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Body mass index 25.0-34.9 kg/m2, generally healthy and mobile.

You may not qualify if:

• Currently smoke tobacco.
• e-cigarettes, or used smokeless tobacco.
• Diagnosed neuromuscular disease.
• Diagnosed diabetes,
• Diagnosed high blood pressure.
• Diagnosed cancer.
• Previous heart attack or other chronic heart related conditions.
• Difficulty moving without assistive devices.
• Difficulty walking one quarter mile.
• Taking medications that influence muscle size.
• Previous bariatric surgery.
• Greater than 350 lbs in body mass.
• Currently on a dietary or exercise program.
• At risk for disordered eating via self-report.

Sponsors & Collaborators

• Kyle Hackney: lead
• University of Nebraska: collaborator

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: January 31, 2019
• Study Start: October 8, 2018
• Primary Completion: December 16, 2019
• Study Completion: March 31, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

US (1)