NCT05420181

Brief Summary

Recent research shows that timing of nutritional intake and daily periods of fasting may have important health effects. In humans, limiting daily food intake to a narrow window (typically \~8 hours) can bring about some beneficial changes in blood concentrations of fats, sugar and the hormone insulin. It is thought that many of these changes are due to the prolonged daily fasting periods and humans will have regularly experienced prolonged fasting periods throughout evolution. 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. We have recently shown that extending habitual daily periods of fasting to 16 hours per day also improves the ability of skeletal muscle to take up amino acids, the building blocks of protein. We are interested in studying whether a single episode of prolonged overnight fast (\~16 hours), when compared to a normal overnight fast of 10 hours, is sufficient to stimulate skeletal muscle protein synthesis in response to dietary protein ingestion in healthy humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

4.8 years

First QC Date

April 8, 2022

Last Update Submit

November 18, 2025

Conditions

Keywords

Energy metabolismskeletal muscleprotein synthesis

Outcome Measures

Primary Outcomes (5)

  • Whole body Insulin sensitivity

    Postprandial blood glucose and serum insulin concentrations will be used to compute the Matsuda index of whole body insulin sensitivity. Postprandial blood glucose and serum insulin concentrations will be measured every 15mins for 3 hours in response to ingestion of a protein and dextrose drink. Serum insulin concentration (mIU/l) will be measured either with an enzyme linked immunosorbent assay or a radioimmuno assay. Blood glucose will be measured using the glucose oxidase method.

    3 hours

  • Glycemic responses

    Postprandial blood glucose incremental area under the curve( iAUC)

    3 hours

  • Insulinaemic responses

    Postprandial blood insulin iAUC

    3 hours

  • Index of skeletal muscle protein synthesis (A)

    Skeletal muscle branched chain amino acid uptake using postprandial arteriovenous differences.

    3 hours

  • Index of skeletal muscle protein synthesis (B)

    Muscle protein synthesis will be measured 3 hours after ingestion of a protein and dextrose drink in which the milk protein has been intrinsically labelled with \[1-13C\]phenylalanine. The investigators will measure \[13C\]phenylalanine incorporation into the muscle myofibrillar protein pool during the 3 hour period from a muscle biopsy sample taken pre ingestion of the drink and a muscle biopsy taken 3 hours post ingestion. This will give a rate (%/hour) of muscle protein synthesis.

    3 hours

Secondary Outcomes (1)

  • Skeletal muscle insulin sensitivity

    3 hours

Study Arms (2)

Short Fast

OTHER

Participants will fast overnight for a period of 10 hours

Other: Short 10hr fast

Long fast

OTHER

Participants will fast overnight for a period of 16 hours

Other: Long 16h fast

Interventions

Participants will fast from 11pm the night before the study day

Short Fast

Participants will fast from 5pm the night before the study day

Long fast

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • yrs
  • healthy
  • non-smoking
  • physically active
  • no excessive weight loss in past 6 months
  • body mass index between 18 and 27 kg.m-2

You may not qualify if:

  • body mass index under 18 and over 27 kg.m-2
  • sedentary
  • screening bloods out of range
  • excessive weight loss in the past 6 months
  • irregular eating patterns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (5)

  • Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17.

    PMID: 22608008BACKGROUND
  • Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Cell Metab. 2014 Dec 2;20(6):991-1005. doi: 10.1016/j.cmet.2014.11.001.

    PMID: 25470547BACKGROUND
  • Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.

    PMID: 27737674BACKGROUND
  • Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.

    PMID: 29754952BACKGROUND
  • 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: 32729615BACKGROUND

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Physiology

Study Record Dates

First Submitted

April 8, 2022

First Posted

June 15, 2022

Study Start

May 30, 2019

Primary Completion

March 19, 2024

Study Completion

March 19, 2024

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations