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Completed

NCT Number: NCT05420181

Prolonged Overnight Fast, Energy Metabolism and Skeletal Muscle Anabolic Sensitivity

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

There is a growing interest in the cardiometabolic benefits of various intermittent fasting paradigms (such as alternate day fasting and the 5:2 fast diet), where periods of normal energy intake are punctuated by periods of energy restriction or fasting. A recent alternative to these protocols is time-restricted feeding (TRF), which limits daily food/energy intake to a narrow window (typically 8 to 10h). The major strength of TRF is that it extends the duration of overnight fast without limiting normal calorie intake. Recent evidence from both animal and human studies have shown that habitual daily periods of fasting of as little as 16h can reduce fasting insulin and triglycerides levels, protect against excessive body weight gain in response to high fat and sucrose diets, better maintain fat-free mass, and improve beta-cell responsiveness. We recently completed a 2-week TRF intervention study using the 8h fed (between 8am and 4pm)/16h fast protocol in healthy individuals and found improvements in insulin sensitivity and skeletal muscle uptake of branched chain amino acids. As we did not make measurements of muscle protein synthesis, it is not known whether a single episode of prolonged overnight fast (~16h) is sufficient to elicit improvements in insulin sensitivity and stimulate skeletal muscle protein synthesis in response to dietary protein ingestion. The aim of the proposed study is to investigate the effect of prolonged overnight fast (16h vs. 10h) on postprandial energy metabolism and skeletal muscle protein synthesis in healthy humans.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male
  • 18-35yrs
  • healthy
  • non-smoking
  • physically active
  • no excessive weight loss in past 6 months
  • body mass index between 18 and 27 kg.m-2

Exclusion criteria

  • 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

Treatment and study plan

Short 10hr fast

Other

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

Long 16h fast

Other

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

Primary outcomes

  1. Whole body Insulin sensitivity

    Time frame: 3 hours

    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.

  2. Glycemic responses

    Time frame: 3 hours

    Postprandial blood glucose incremental area under the curve( iAUC)

  3. Insulinaemic responses

    Time frame: 3 hours

    Postprandial blood insulin iAUC

  4. Index of skeletal muscle protein synthesis (A)

    Time frame: 3 hours

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

  5. Index of skeletal muscle protein synthesis (B)

    Time frame: 3 hours

    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.

Secondary outcomes

  1. Skeletal muscle insulin sensitivity

    Time frame: 3 hours

    Postprandial arteriovenous differences in glucose concentration. Blood glucose in arterialised and deep venous blood across the forearm will be measured using the glucose oxidase method.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

The Effect of Prolonged Overnight Fast on Postprandial Energy Metabolism and Skeletal Muscle Anabolic Sensitivity in Healthy Humans

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Nov 24, 2025

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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