Body CompositionNCT06061315
Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
A study of Body Composition and Lean Body Mass, run by University of Southern Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Lean Body Mass, Muscle Strength
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2023to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark
Odense, 5000
About this study
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).
Read the detailed description
Participants will perform supervised resistance training involving (Leg press, pull down, chest press, back extension and abdominal crunches) 3 times a week for 12 weeks. Participants will consume either placebo or collagen peptides (in a double blinded study design) just following resistance training on training days (And approximately the same time of day on non-training days). Prior to, and following 12 weeks of exercise, participants will be tested in body composition, maximal and explosive, isometric muscle strength, resting metabolism, health parameters. Additionally, blood samples will be taken to ensure health and training eligibility and safety.
Participants are healthy untrained overweight males (30-60 yrs)
- Conditions
- Body Composition, Lean Body Mass, Muscle Strength, Muscle Power
- Being tested
- Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained men, Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained menDietary supplement
The effects of collagen peptide consumption in combination with resistance training will be tested
Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained menDietary supplement
The effects of placebo consumption in combination with resistance training will be tested
| Study group | Role | What they receive |
|---|---|---|
| Collagen peptide group | Experimental | This group will consume 1 serving of Collagen peptides, which is produced and marketed ® by GELITA AG, Germany under the brand name BODYBALANC each day. Receives: Dietary Supplement: Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained men |
| Placebo group | Placebo comparator | This 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. Receives: Dietary Supplement: Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass (kg)
Lean body mass measured by dual-energy X-ray absorptiometry (DXA)
Measured: 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)
Fat mass measured by dual-energy X-ray absorptiometry (DXA)
Measured: 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)
Resting energy expenditure measured with the ventilated hood and indirect calorimetry
Measured: 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)
1 repetition maximum strength in leg press, pull down and chest press
Measured: 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)
Maximal isometric knee extensor force
Measured: 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)
Unilateral rate of force development from onset of force until 0-30, 0-50, 0-100, 0-200ms of the knee extensor
Measured: 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
Knee extensor power (W)
Unilateral knee extensor power (W)
Measured: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 15 minutes
Sit to stand
30 second sit to stand test
Measured: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 3 minutes
Full body bone mineral density (g/cm^2)
Full body bone mineral density (BMD) (obtained by DEXA)
Measured: 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
Blood sampling
Blood samples collected from the antecubital vein in a fasted state. Measurements of Hb1Ac, insulin, glucose, total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides, HOMA-IR, Non-HDL cholesterol (Total - HDL), Total cholesterol / HDL ratio
Measured: Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start15 Sep 2023
- Primary completion23 Nov 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Collagen Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061315
- Sponsor's protocol ID
- 7260992052
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
- ClinicalTrials.gov ID
- NCT06061315
- Acronym / sponsor ID
- 7260992052
- Conditions
- Body Composition, Lean Body Mass, Muscle Strength, Muscle Power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Collagen Research Institute
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Participants will perform supervised resistance training involving (Leg press, pull down, chest press, back extension and abdominal crunches) 3 times a week for 12 weeks. Participants will consume either placebo or collagen peptides (in a double blinded study design) just following resistance training on training days (And approximately the same time of day on non-training days). Prior to, and following 12 weeks of exercise, participants will be tested in body composition, maximal and explosive, isometric muscle strength, resting metabolism, health parameters. Additionally, blood samples will be taken to ensure health and training eligibility and safety.
Participants are healthy untrained overweight males (30-60 yrs)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Collagen peptide group | Experimental | Dietary Supplement: Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained menThis 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 comparator | Dietary Supplement: Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained menThis 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained menThe effects of collagen peptide consumption in combination with resistance training will be tested | Dietary supplement | Collagen peptide group |
| Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained menThe effects of placebo consumption in combination with resistance training will be tested | Dietary supplement | Placebo group |
Primary outcome
Lean body mass (kg)
Time frame: Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 20 minutes for all dxa-measurements
Lean body mass measured by dual-energy X-ray absorptiometry (DXA)
9 secondary outcomes
Fat mass (kg)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Knee extensor power (W)
Time frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 15 minutes
Sit to stand
Time frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 3 minutes
Full body bone mineral density (g/cm^2)
Time frame: 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
Blood sampling
Time frame: Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Body Composition
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Active, not recruitingObservational study
Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)
Geriatric Assessment, Advanced Cancer
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Multimodal Assessment of Sarcopenia Using Shear Wave Elastography, Dual-Energy X-ray Absorptiometry, Bioelectrical Impedance Analysis, and Physical Performance Measures
Sacropenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Body Composition and Lean Body Mass, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean body mass (kg) (time frame: Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 20 minutes for all dxa-measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.