Forearm Immobilization, Metabolic Health, and Nutrition

NCT04626401 | Completed

• 1 other identifier: 200617
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Forearm glucose uptake

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

  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.

Secondary Outcomes (4)

• Muscle protein synthesis rates

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

• Intramuscular BCAA concentration

  Before and after 3 hours of hyperinsulinaemic-euglycaemic clamped conditions

• BCAA concentrations between forearm arterialized venous and deep venous blood

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

• Whole-body substrate oxidation

  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)

Study Arms (2)

Control diet during immobilisation

PLACEBO COMPARATOR

A 2 day controlled dietary intervention.

Behavioral: Forearm immobilization

Branched chain amino acid restricted diet during immobilisation

EXPERIMENTAL

A 2 day branched chain amino acid restricted dietary intervention.

Behavioral: Forearm immobilization

Interventions

Forearm immobilization BEHAVIORAL

Two days of forearm immobilization

Branched chain amino acid restricted diet during immobilisation; Control diet during immobilisation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Wellcome Trust: collaborator

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Officials

• Marlou Dirks, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 12, 2020
• Study Start: June 24, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)