NCT03571048

Pilot Study of Time Restricted Feeding as a Weight Loss Intervention

Completed NA Results posted Last updated 25 October 2022

What this trial tests

NA trial testing Reduced Calorie Diet (RCD) in Obesity in 95 participants. Completed in 12 November 2020.

Timeline

1 June 2018

Primary endpoint
14 May 2020

12 November 2020

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	1 June 2018
Primary completion	14 May 2020
Estimated completion	12 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Reduced Calorie Diet (RCD)
• Time Restricted Feeding (TRF)

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 50, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Body Weight Primary · Baseline, 12 weeks

Body weight will be measured via clinic scale.

Group	Value	95% CI
Reduced Calorie Diet (RCD)	-5.1	± 3.2
Time Restricted Feeding (TRF)	-6.2	± 4.1

Changes in Fat Mass Secondary · Baseline, 12 weeks

Body composition will be assessed with dual-energy x-ray absorptiometry (DXA).

Group	Value	95% CI
Reduced Calorie Diet (RCD)	-2.1	± 2.6
Time Restricted Feeding (TRF)	-2.8	± 1.8

Changes in Objectively Measured Energy Intake (Camera) Secondary · Baseline, 12 weeks

All energy intake events will be recorded using the camera function on a cell phone application

Group	Value	95% CI
Reduced Calorie Diet (RCD)	-612.2	± 476
Time Restricted Feeding (TRF)	-647.3	± 773

Changes in Physical Activity Secondary · Baseline, 12 weeks

Step count will be measured with activity monitors.

Group	Value	95% CI
Reduced Calorie Diet (RCD)	576	± 3172
Time Restricted Feeding (TRF)	596	± 2731

Changes in Sedentary Behavior Secondary · Baseline, 12 weeks

Sitting time will be measured with activity monitors.

Group	Value	95% CI
Reduced Calorie Diet (RCD)	-19.8	± 88
Time Restricted Feeding (TRF)	-0.77	± 82

6 Month Post-Intervention Follow-Up Body Weight Secondary · 24 weeks after completion of the 12-week intervention (i.e. at week 36)

Body weight will be measured via clinic scale at 6 months post-intervention

Group	Value	95% CI
Reduced Calorie Diet (RCD)	-4.3	± 5.3
Time Restricted Feeding (TRF)	-4.9	± 5.3

6 Month Post-Intervention Follow-Up Fat Mass Secondary · 24 weeks after completion of the 12-week intervention (i.e. at week 36)

Body composition will be assessed with dual-energy x-ray absorptiometry (DXA).

Group	Value	95% CI
Reduced Calorie Diet (RCD)	-2.6	± 4.4
Time Restricted Feeding (TRF)	-3.5	± 4

Sponsor's own description

The circadian timing of Energy Intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating later in the evening or at night when the circadian system is promoting sleep adversely influences weight loss. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful weight loss strategy. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators aims are to: 1) Assess processes critical for the success of a large-scale trial comparing the efficacy of a reduced calorie diet with time restricted feeding (RCD+TRF) versus standard RCD on weight loss; 2) Develop methodology to assess compliance to the RCD+TRF versus standard RCD program and collect preliminary data on whether the programs have differential effects on free-living behaviors (EI, appetite, physical activity, and sedentary behavior); and 3) Measure metabolic responses to RCD+TRF versus standard RCD to determine candidate mechanisms related to weight loss at 12wks and weight maintenance at 6mo post-intervention. The investigators primary hypothesis is that weight loss will be greater in the TRF group compared to the RCD group.

Publications & conference data

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

1. Early time-restricted eating compared with daily caloric restriction: A randomized trial in adults with obesity.
   Thomas EA, Zaman A, Sloggett KJ, Steinke S, et al · · 2022 · cited 74× · PMID 35470974 · DOI 10.1002/oby.23420
2. Later Meal and Sleep Timing Predicts Higher Percent Body Fat.
   Thomas EA, Zaman A, Cornier MA, Catenacci VA, et al · · 2020 · cited 45× · PMID 33383648 · DOI 10.3390/nu13010073
3. Improving lifestyle obesity treatment during the COVID-19 pandemic and beyond: New challenges for weight management.
   Caldwell AE, Thomas EA, Rynders C, Holliman BD, et al · · 2022 · cited 20× · PMID 34540266 · DOI 10.1002/osp4.540
4. The Effect of Intermittent Fasting on Appetite: A Systematic Review and Meta-Analysis.
   Elsworth RL, Monge A, Perry R, Hinton EC, et al · · 2023 · cited 17× · PMID 37299567 · DOI 10.3390/nu15112604
5. The effects of the COVID-19 pandemic on weight loss in participants in a behavioral weight-loss intervention.
   Zaman A, Sloggett KJ, Caldwell AE, Catenacci VA, et al · · 2022 · cited 11× · PMID 35118814 · DOI 10.1002/oby.23399
6. 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
7. The effects of early time restricted eating plus daily caloric restriction compared to daily caloric restriction alone on continuous glucose levels.
   Zaman A, Grau L, Jeffers R, Steinke S, et al · · 2024 · cited 4× · PMID 38264001 · DOI 10.1002/osp4.702