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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Muscle Protein Synthesis
• Intervention / Treatment: Behavioral: Resistance exercise; Dietary supplement: Collagen protein

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luc JC van Loon, PhD; Phone Number: +31-43-3881397; Email: l.vanloon@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6200 MD
    • Maastricht University Medical Centre
    • Principal Investigator: Luc JC van Loon, PhD
    • Contact: Thorben Aussieker, MSc; Email: t.aussieker@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen protein; 100 g of collagen peptides (in boluses) with vitamin C	Behavioral: Resistance exercise; A single resistance exercise session of the leg press and leg extension exercise; 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
Placebo Comparator: Placebo; Non-caloric placebo (flavoured water) drinks, with vitamin C.	Behavioral: Resistance exercise; A single resistance exercise session of the leg press and leg extension exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Plasma insulin concentrations	Plasma insulin concentrations	measured over the 8 hour post-prandial period
Plasma amino acids concentrations	Plasma amino acids concentrations	measured over the 8 hour post-prandial period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary macronutrient intake	assessed by written dietary intake records	2 days before test days
Age	age in years	baseline
Body mass	body mass in kg	baseline
Height	Height in m	baseline
Lean mass	Measured by DXA	baseline
One repetition maximum of the legs	maximum strength of both legs	baseline

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Luc JC van Loon, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: METC 22-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No