Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
1 other identifier
interventional
80
1 country
1
Brief Summary
The effect of resistance training with post-exercise Collagen peptides (CP) supplementation on lean body mass, maximal and explosive, isometric muscle strength as well as fat mass, resting metabolism, health parameters and compared to resistance training alone will be evaluated in a group of untrained overweight male (30-60 yrs) population in a randomized controlled trial (RCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedStudy Start
First participant enrolled
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2024
CompletedMay 5, 2026
April 1, 2026
1.2 years
September 13, 2023
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Lean body mass (kg)
Lean body mass measured by dual-energy X-ray absorptiometry (DXA)
Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 20 minutes for all dxa-measurements
Secondary Outcomes (9)
Fat mass (kg)
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 20 minutes for all dxa-measurements
Resting energy expenditure (kcal pr. day)
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - 15-25 minutes in total
1 Repetition maximum strength (kg)
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 25 minutes for all 1RM measurements
Maximal isometric knee extensor force (Nm)
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 25 minutes for all isokinetic dynamometer measurements
Rate of force development (Nm/sec)
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 25 minutes for all isokinetic dynamometer measurements
- +4 more secondary outcomes
Other Outcomes (14)
Dietary intake
Pre (1 week prior to intervention) and during the intervention period (week 10 if the intervention) - N/A
Systolic and diastolic of the ankle and brachii (mm/Hg)
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 3 minutes
Questionnaires about health status (36-Item Short Form Survey (SF-36))
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
- +11 more other outcomes
Study Arms (2)
Collagen peptide group
EXPERIMENTALThis group will consume 1 serving of Collagen peptides, which is produced and marketed ® by GELITA AG, Germany under the brand name BODYBALANC each day.
Placebo group
PLACEBO COMPARATORThis group will consume 1 serving of silicon dioxide (Sipernat 350, Evonik, Germany) each day. The product is absorbed in negligible amounts by the intestine and does therefore induce minor metabolic effects.
Interventions
The effects of collagen peptide consumption in combination with resistance training will be tested
The effects of placebo consumption in combination with resistance training will be tested
Eligibility Criteria
You may qualify if:
- Male, between 30 and 60 years of age
- Fat mass \>25 % as measured by bioelectrical impedance analysis
- Stable weight (±5 %) and eating behaviour within the last 3 months.
- Signed informed consent
You may not qualify if:
- Regular physical activity \>60 min / week
- Stabile or progressive diseases/conditions (including medication) contraindicating or disabling participation in intensive exercise training and/or with potential to affect training adaptation beyond normal variation. For example:
- Contraindications against physical stress corresponding guidelines of American College of Sports Medicine (ACSM)
- Subjective symptoms during exercise (e.g., unusual physical exhaustion, dyspnoea, nausea)
- Moderate to severe mobility limitation (i.e., due to rheumatic disease)
- Diagnosis of cancer within the last 5 years
- Diabetes mellitus I and II uncontrolled arterial hypertension (systolic blood pressure \>155 for mmHg and/or diastolic blood pressure \>94 mm Hg; mild hypertension under resting condition will be allowed but such participants will be recommended to consult their general practitioner).
- Conditions contraindicating the supplementation protocol.
- Contraindications against nutritional or ergogenic supplements
- Allergy/aversion against animal protein
- Liver or kidney diseases with a non-permission to ingest certain concentrations of protein.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark
Odense, 5000, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants will be allocated to either placebo or collagen peptide supplementation in a double blinded randomized design. Only following completion of all participants will the blinding be removed
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2023
First Posted
September 29, 2023
Study Start
September 15, 2023
Primary Completion
November 23, 2024
Study Completion
November 23, 2024
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share