Muscle Anabolic Response to β2-adrenergic Stimulation With Increased Amino Acid Availability.

NCT06654986 | Recruiting

• 1 other identifier: SALM_chron
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women.

Conditions

Healthy

Keywords

Beta2-adrenergic stimulation; Amino acid availability; Skeletal muscle hypertophy

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle hypertrophy

  Muscle hypertrophy measured using Dual-energy X-ray Absorptiometry (DXA).

  Through study completion, an average on 7 weeks

Secondary Outcomes (3)

• Quadriceps strength

  Through study completion, an average on 7 weeks

• Power output during sprint testing

  Through study completion, an average on 7 weeks

• Power output during time trial

  Through study completion, an average on 7 weeks

Other Outcomes (1)

• Maximal oxygen uptake

  Through study completion, an average on 7 weeks

Study Arms (3)

Salmeterol + amino acid availability

EXPERIMENTAL

The participants will be administered salmeterol from an inhaler device and amino acid availability (protein powder in a shaker) daily during a 6-week intervention.

Drug: Salmeterol + amino acid availability

Salmeterol + placebo

EXPERIMENTAL

The participants will be administered salmeterol from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention.

Placebo + placebo

PLACEBO COMPARATOR

The participants will be administered placebo from an inhaler device. Furthermore they will be administered placebo (carbo fuel in a shaker) daily during a 6-week intervention.

Drug: Placebo + placebo

Interventions

Salmeterol + amino acid availability DRUG

The participants will be administered 200 µg salmeterol (8 puffs) from a MDI device and 40 g amino acid availability (clear whey in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.

Salmeterol + amino acid availability

Salmeterol + placebo DRUG

The participants will be administered 200 µg salmeterol (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.

Placebo + placebo DRUG

The participants will be administered placebo (8 puffs) from a MDI device. Furthermore they will be administered 80 g placebo (carbo fuel in a shaker with water) daily during a 6-week intervention. Participants will be instructed to provide documentation of both the inhalation and the shaker intake via video.

Placebo + placebo

Eligibility Criteria

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

You may qualify if:

• Age 18-40
• Physically active \>5 hours a week
• Maximum oxygen uptake classified as high or very high

You may not qualify if:

• Active smoker currently or within the past 5 years
• Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
• Chronic or acute illness deemed by the responsible study physician to affect the test parameters
• Deviation from the study protocol
• Lean mass index \>21 kg/m²
• Pregnancy
• Smoker
• Blood donation during the past 3 months

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Salmeterol Xinafoate

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Thirty-six healthy, well-trained men and women will be randomized into three distinct groups, each receiving one of the following interventions: 1) salmeterol with amino acid availability, 2) salmeterol, or 3) a placebo, administered twice daily over a 6-week intervention period. This design aims to elucidate the impact of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

DK (1)