Clinical trial NCT04626401: Forearm Immobilization, Metabolic Health, and Nutrition
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2020-11-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Forearm glucose uptake
timeFrame: 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:
measure: Muscle protein synthesis rates
timeFrame: During 3 hours of hyperinsulinaemic-euglycaemic clamped conditions before and after 2 days of immobilisation
measure: Intramuscular BCAA concentration
timeFrame: Before and after 3 hours of hyperinsulinaemic-euglycaemic clamped conditions
measure: BCAA concentrations between forearm arterialized venous and deep venous blood
timeFrame: Fasted and during the steady-state phase of the insulin clamp (i.e. last 30 minutes)
measure: Whole-body substrate oxidation
timeFrame: 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)
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Marlou Dirks, PhD
role: PRINCIPAL_INVESTIGATOR
References: