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Completed

NCT Number: NCT04626401

Forearm Immobilization, Metabolic Health, and Nutrition

The present study will investigate the impact of dietary branched chain amino acid restriction on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

About this study

Twenty-four healthy young volunteers will undergo 2 days of forearm immobilization in combination with either a branched chain amino acid restricted diet or a control diet. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females 18-40 years of age
  • Body mass index between 18.5 and 30 kg/m2

Exclusion criteria

  • Smoking
  • Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
  • Any diagnosed cardiovascular disease
  • Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
  • Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
  • Regular use of nutritional supplements
  • Currently involved in a structured progressive resistance training programme (>3 times per week)
  • A personal or family history of thrombosis, epilepsy, seizures or schizophrenia
  • Any previous motor disorders or disorders in muscle and/or lipid metabolism
  • Known hypokalaemia
  • Presence of an ulcer in the stomach or gut and/or strong history of indigestion
  • Known severe kidney problems
  • Pregnant or breastfeeding
  • Unable to give consent

Treatment and study plan

Forearm immobilization

Behavioral

Two days of forearm immobilization

Primary outcomes

  1. Forearm glucose uptake

    Time frame: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Forearm glucose uptake is measured during the steady state period of the clamp.

    Insulin sensitivity, measured as forearm glucose uptake, under hyperinsulinaemic-euglycaemic conditions

Secondary outcomes

  1. Muscle protein synthesis rates

    Time frame: During 3 hours of hyperinsulinaemic-euglycaemic clamped conditions before and after 2 days of immobilisation

    Muscle protein synthesis rates are measured using an intravenously infused stable isotope labelled amino acid tracer, combined with repeated blood and muscle tissue sampling.

  2. Intramuscular BCAA concentration

    Time frame: Before and after 3 hours of hyperinsulinaemic-euglycaemic clamped conditions

    Intramuscular BCAA concentration measured using mass spectrometry

  3. BCAA concentrations between forearm arterialized venous and deep venous blood

    Time frame: Fasted and during the steady-state phase of the insulin clamp (i.e. last 30 minutes)

    Arterialized venous-deep venous forearm balance of BCAA, in the fasted state and during a hyperinsulinaemic-euglycaemic clamp

  4. Whole-body substrate oxidation

    Time frame: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Whole-body substrate oxidation is measured before the commencement of, and during the steady state period of the clamp (last 30 minutes)

    Whole-body substrate oxidation measured using indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Wellcome Trust

Registry information

Official study title

The Impact of Dietary Branched-chain Amino Acid (BCAA) Restriction on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2020
Registry last updated
Aug 25, 2022

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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