NCT03823872

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

Completed NA Last updated 25 August 2020

What this trial tests

NA trial testing Time restricted feeding in Overweight and Obesity in 21 participants. Completed in 31 March 2020.

Timeline

8 October 2018

Primary endpoint
16 December 2019

31 March 2020

Quick facts

Lead sponsor	Kyle Hackney
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	8 October 2018
Primary completion	16 December 2019
Estimated completion	31 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Time restricted feeding
• Normal feeding

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Weight Loss — all drugs for Weight Loss →

Sponsor

Kyle Hackney

Who can join

Adults 35 to 60, any sex, with Overweight and Obesity or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Time-restricted eating and concurrent exercise training reduces fat mass and increases lean mass in overweight and obese adults.
   Kotarsky CJ, Johnson NR, Mahoney SJ, Mitchell SL, et al · · 2021 · cited 85× · PMID 34042299 · DOI 10.14814/phy2.14868
2. Effects of Intermittent Fasting in Human Compared to a Non-intervention Diet and Caloric Restriction: A Meta-Analysis of Randomized Controlled Trials.
   Gu L, Fu R, Hong J, Ni H, et al · · 2022 · cited 38× · PMID 35586738 · DOI 10.3389/fnut.2022.871682
3. Comparing caloric restriction regimens for effective weight management in adults: a systematic review and network meta-analysis.
   Huang J, Li Y, Chen M, Cai Z, et al · · 2024 · cited 6× · PMID 39327619 · DOI 10.1186/s12966-024-01657-9