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

NCT06435637 | Not Yet Recruiting DMC

• 1 other identifier: METC 22-018
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Protein Synthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Muscle connective protein synthesis rates exercised leg

  one value calculated over 8 hours

• Myofibrillar protein synthesis rates rested leg

  one value calculated over 8 hours

• Myofibrillar protein synthesis rates exercised leg

  one value calculated over 8 hours

• Skin protein synthesis rates

  one value calculated over 8 hours

• Plasma insulin concentrations

  measured over the 8 hour post-prandial period

Other Outcomes (6)

• Age

  baseline

• Dietary macronutrient intake

  2 days before test days

• Body mass

  baseline

Study Arms (2)

Collagen protein

EXPERIMENTAL

100 g of collagen peptides (in boluses) with vitamin C

Dietary Supplement: Collagen protein; Behavioral: Resistance exercise

Placebo

PLACEBO COMPARATOR

Non-caloric placebo (flavoured water) drinks, with vitamin C.

Behavioral: Resistance exercise

Interventions

Collagen protein DIETARY_SUPPLEMENT

Ingestion of 40, 20, 20 and 20 gram of collagen protein right after and every 2 hours after a bout of exercise

Collagen protein

Resistance exercise BEHAVIORAL

A single resistance exercise session of the leg press and leg extension exercise

Collagen protein; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• ≤ BMI ≤ 30 kg/m2
• No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luc JC van Loon, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luc JC van Loon, PhD

CONTACT

+31-43-3881397; l.vanloon@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, parallel-group, placebo-controlled intervention study

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

NL (1)