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Completed

NCT Number: NCT03969745

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Nottingham, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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%)

Treatment and study plan

Time restricted feeding

Behavioral

Restrict energy intake window to between 8am and 4pm

Caloric restriction

Behavioral

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

Primary outcomes

  1. Change in glucose uptake

    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

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

  2. Change in branched chain amino acid uptake

    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

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

  3. Change in whole-body insulin sensitivity

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

    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.

Secondary outcomes

  1. Change in body composition

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

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

  2. Change in body composition

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

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

  3. Change in substrate metabolism

    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.

    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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Acronym: TRF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 31, 2019
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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