Effects of Two-weeks of Time Restricted Feeding on Basal and Postprandial Metabolism in Healthy Men

NCT03969745 | Completed

• 1 other identifier: 19-1705
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

In the modern era, food access is widely available and it is not uncommon for the time between breakfast and a late night snack to exceed 14 hours. The investigators are interested in studying whether limiting this window to 8 hours will have any beneficial effects of human health as has been demonstrated in animal models. Eight men were asked to restrict their energy intake window to between 8 am and 4 pm for two weeks whilst maintaining their habitual diet (quantity and composition). Improvements in skeletal muscle and whole-body insulin sensitivity were observed but these were potentially confounded by an average weight loss of 1 kg. Therefore an additional control group was recruited to follow a daily caloric deficit of \~400 kilocalories without changing the timing of intake.

Conditions

Metabolic Health

Keywords

chrononutrition; metabolism; body composition

Outcome Measures

Primary Outcomes (3)

• Change in glucose uptake

  The arterio-venous forearm balance method was used to assess skeletal muscle glucose uptake in micromoles/min.

  Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink

• Change in branched chain amino acid uptake

  The arterio-venous forearm balance method was used to assess skeletal muscle branched chain amino acid uptake in micromoles/min.

  Pre and post intervention (15 days apart). Fasted blood samples and every 10 min for 3 hours following consumption of carbohydrate + protein drink

• Change in whole-body insulin sensitivity

  The Matsuda Index was used to calculate an index of whole-body insulin sensitivity using values of fasted and postprandial glucose and insulin. Measured in arbitrary units and higher values indicates increased insulin sensitivity. All individual changes will be reported.

  Pre and post intervention (15 days apart).

Secondary Outcomes (3)

• Change in body composition

  Pre and post intervention (15 days apart)

• Change in body composition

  Pre and post intervention (15 days apart)

• Change in substrate metabolism

  Pre and post intervention (15 days apart). In each condition there was one measurement in the fasted state and two measurements in the postprandial state.

Study Arms (2)

Time restricted feeding (TRF)

EXPERIMENTAL

Participants restricted their daily energy intake window to between 8 am and 4 pm for two weeks. They were encouraged to not alter the quantity and composition of their diet or alter physical activity patterns.

Behavioral: Time restricted feeding

Caloric deficit

ACTIVE COMPARATOR

The investigators observed significant weight loss in the TRF group with participants reporting to consume \~400 kilocalories less per day. Therefore the investigators added a caloric deficit group to control for the effects of weight loss on metabolism. Total energy expenditure was measured for one week and was used to prescribe a 400 kilocalories/day energy deficit diet to follow for two weeks.

Behavioral: Caloric restriction

Interventions

Time restricted feeding BEHAVIORAL

Restrict energy intake window to between 8am and 4pm

Time restricted feeding (TRF)

Caloric restriction BEHAVIORAL

Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing

Caloric deficit

Eligibility Criteria

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

You may qualify if:

• Healthy male between 18 and 35 years old
• Body mass index between 18 and 27.5 kg.m\^-2
• Regular breakfast consumer, 5 or more days per week
• Moderate physical activity level (PAL between 1.6 and 2)

You may not qualify if:

• Smoking
• Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (heart or blood) abnormalities including hypertension.
• Clinically significant abnormalities on screening including ECG abnormalities
• Routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
• High alcohol consumption (Routinely \>4 units per day)
• Eating attitudes test (EAT-26) score \> 20
• On an energy-restricted diet
• Significant body mass fluctuation in previous 3 months (\>5%)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

MRC/ARUK Centre for Musculoskeletal Ageing, School of Life Sciences, University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Jones R, Pabla P, Mallinson J, Nixon A, Taylor T, Bennett A, Tsintzas K. Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men. Am J Clin Nutr. 2020 Oct 1;112(4):1015-1028. doi: 10.1093/ajcn/nqaa192.

  PMID: 32729615 DERIVED

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kostas Tsintzas, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants monitored for a one week baseline period before being allocated to either a caloric deficit group or a time-restricted feeding group for two weeks.

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 31, 2019
• Study Start: June 26, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)