Effects of Ingesting Multiple Boluses of Collagen on Muscle & Skin Connective Protein Synthesis in Vivo in Humans

Muscle Protein Synthesis Clinical Trial

— CODIAK  

Official title:

Collagen Digestion and Amino Acid Absorption Kinetics and the Effect on Muscle & Skin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435637
• Other study ID #: METC 22-018
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Maastricht University Medical Center
• Contact: Luc JC van Loon, PhD
• Phone: +31-43-3881397
• Email: l.vanloon[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans.

Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans.

Study design: Double-blind, parallel-group, placebo-controlled intervention study.

Study population: 20 healthy young males, aged 18-35 years.

Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue.

Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Aged between 18-35 years

• Male

• Healthy, recreationally active (participating in recreational sports activities = 1 and = 6 h per week, with a maximum of 2 h resistance-type exercise)

• 18.5 = BMI = 30 kg/m2

• No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).

Exclusion Criteria:

• Female

• Smoking

• Musculoskeletal disorders

• Metabolic disorders

• Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).

• Chronic use of gastric acid suppressing medication or anti-coagulants

• Unstable weight over the last three months

• Diagnosed GI tract disorders or diseases

• Blood donation in the past 2 months

Related Conditions & MeSH terms

• Muscle Protein Synthesis

Intervention

Dietary Supplement:
• Collagen protein
Ingestion of 40, 20, 20 and 20 gram of collagen protein right after and every 2 hours after a bout of exercise

Behavioral:
• Resistance exercise
A single resistance exercise session of the leg press and leg extension exercise

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	age in years	baseline
Other	Dietary macronutrient intake	assessed by written dietary intake records	2 days before test days
Other	Body mass	body mass in kg	baseline
Other	Height	Height in m	baseline
Other	Lean mass	Measured by DXA	baseline
Other	One repetition maximum of the legs	maximum strength of both legs	baseline
Primary	Muscle connective protein synthesis rates rested leg	The primary analysis will be an independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.	one value calculated over 8 hours
Secondary	Muscle connective protein synthesis rates exercised leg	Independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.	one value calculated over 8 hours
Secondary	Myofibrillar protein synthesis rates rested leg	Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.	one value calculated over 8 hours
Secondary	Myofibrillar protein synthesis rates exercised leg	Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.	one value calculated over 8 hours
Secondary	Skin protein synthesis rates	Independent t-test, comparing postprandial skin protein synthesis rates over the 0-8 h period (i.e., one integrated value).	one value calculated over 8 hours
Secondary	Plasma insulin concentrations	Plasma insulin concentrations	measured over the 8 hour post-prandial period
Secondary	Plasma amino acids concentrations	Plasma amino acids concentrations	measured over the 8 hour post-prandial period