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CompletedNCT03969745TRFUpdated Sep 9, 2019

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

An interventional study of Time restricted feeding and Caloric restriction in Metabolic Health, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-09.

Sponsored by University of Nottingham · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jun 2017, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
Male
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Study 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.

Read the detailed description

All participants were monitored for a one week baseline period to establish their habitual physical activity and dietary patterns. This was done using food diaries, interstitial glucose monitors and a combined heart rate + accelerometer device. Participants consumed a standardised evening meal \~12h before visiting the laboratory to assess their metabolic response to a liquid test meal (1g/kg bodyweight dextrose and 0.4g/kg bodyweight protein) using the arterio-venous forearm balance model. Dual-energy X-ray absorptiometry scans, indirect calorimetry measurements and fasted and postprandial vastus lateralis biopsies were also obtained.

From the next day, participants either restricted their daily energy intake window to between 8 am and 4 pm or were prescribed a caloric deficit diet (\~400 kilocalories/day) for two weeks. Physical activity, interstitial glucose concentrations and dietary patterns were monitored throughout. After this, participants visited the laboratory again to assess changes in metabolism and body composition.

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Conditions studied

  • Metabolic Health

Keywords

  • chrononutrition
  • metabolism
  • body composition
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In context

Lead sponsor

University of Nottingham is the lead sponsor of 463 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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%)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Time restricted feeding (TRF)

    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

  • Active comparator
    Caloric deficit

    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

  • BehavioralTime restricted feeding

    Restrict energy intake window to between 8am and 4pm

  • BehavioralCaloric restriction

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

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What researchers measure

Primary outcomes

  1. Change in glucose uptake

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

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

  2. 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.

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

  3. 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.

    Time frame: Pre and post intervention (15 days apart).

Secondary outcomes

  1. Change in body composition

    Dual-energy X-ray absorptiometry scans to assess changes in fat mass in kg

    Time frame: Pre and post intervention (15 days apart)

  2. Change in body composition

    Dual-energy X-ray absorptiometry scans to assess changes in fat-free mass in kg

    Time frame: Pre and post intervention (15 days apart)

  3. Change in substrate metabolism

    Rates of oxygen consumption and carbon dioxide production were measured using indirect calorimetry. These were used to calculate rates of fat and carbohydrate metabolism in grams/min.

    Time frame: 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.

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Study locations

1 site
  • MRC/ARUK Centre for Musculoskeletal Ageing, School of Life Sciences, University of Nottingham
    Nottingham, NG7 2UH, United Kingdom
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References and documents

Publications

  • 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. PubMed 32729615 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03969745
Responsible party
Sponsor
First posted
May 31, 2019
Start date
Jun 26, 2017
Primary completion
May 30, 2019
Completion
May 30, 2019
Last update
Sep 9, 2019

Study contacts

Kostas Tsintzas, PhD
principal investigator · University of Nottingham

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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