Forearm Immobilization, Metabolic Health, and Nutrition

Healthy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626401
• Other study ID #: 200617
• Status: Completed
• Phase: N/A
• Start date: June 24, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: August 2022
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Forearm immobilization
Two days of forearm immobilization

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle protein synthesis rates	Muscle protein synthesis rates are measured using an intravenously infused stable isotope labelled amino acid tracer, combined with repeated blood and muscle tissue sampling.	During 3 hours of hyperinsulinaemic-euglycaemic clamped conditions before and after 2 days of immobilisation
Secondary	Intramuscular BCAA concentration	Intramuscular BCAA concentration measured using mass spectrometry	Before and after 3 hours of hyperinsulinaemic-euglycaemic clamped conditions
Secondary	BCAA concentrations between forearm arterialized venous and deep venous blood	Arterialized venous-deep venous forearm balance of BCAA, in the fasted state and during a hyperinsulinaemic-euglycaemic clamp	Fasted and during the steady-state phase of the insulin clamp (i.e. last 30 minutes)
Secondary	Whole-body substrate oxidation	Whole-body substrate oxidation measured using indirect calorimetry	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)