Forearm Immobilization, Metabolic Health, and Nutrition

NCT ID: NCT04626401

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2022-06-10

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded

Study Groups

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Control diet during immobilisation

A 2 day controlled dietary intervention.

Group Type PLACEBO_COMPARATOR

Forearm immobilization

Intervention Type BEHAVIORAL

Two days of forearm immobilization

Branched chain amino acid restricted diet during immobilisation

A 2 day branched chain amino acid restricted dietary intervention.

Group Type EXPERIMENTAL

Forearm immobilization

Intervention Type BEHAVIORAL

Two days of forearm immobilization

Interventions

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Forearm immobilization

Two days of forearm immobilization

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlou Dirks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

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University of Exeter

Exeter, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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200617

Identifier Type: -

Identifier Source: org_study_id

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