- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061315
Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
Study Overview
Status
Intervention / Treatment
- Dietary supplement: Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained men
- Dietary supplement: Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained men
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Odense, Denmark, 5000
- The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Collagen peptide group
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.
|
The effects of collagen peptide consumption in combination with resistance training will be tested
|
|
Placebo Comparator: Placebo group
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.
|
The effects of placebo consumption in combination with resistance training will be tested
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Fat mass measured by dual-energy X-ray absorptiometry (DXA)
|
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
|
|
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
|
1 repetition maximum strength in leg press, pull down and chest press
|
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
|
Maximal isometric knee extensor force
|
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
|
Unilateral rate of force development from onset of force until 0-30, 0-50, 0-100, 0-200ms of the knee extensor
|
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
|
Unilateral knee extensor power (W)
|
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
|
30 second sit to stand test
|
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
|
Full body bone mineral density (BMD) (obtained by DEXA)
|
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
|
Resting energy expenditure measured with the ventilated hood and indirect calorimetry
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - 15-25 minutes in total
|
|
Blood sampling
Time Frame: Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 3 minutes
|
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
|
Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 3 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary intake
Time Frame: Pre (1 week prior to intervention) and during the intervention period (week 10 if the intervention) - N/A
|
2*3 days of nutritional intake log
|
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)
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 3 minutes
|
Blood pressure obtained from the ankle and brachii
|
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))
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
|
Questionnaires about health status (SF-36).
The SF-36 consists of eight scaled scores from 0-100.
The lower the score the more disability.
The higher the score the less disability
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
|
|
Questionnaires about physical activity level (The Short questionnaire to Assess Health-enhancing physical activity (SQUASH))
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
|
Questionnaires about activity habits in an average week.
Answers can be calculated to metabolic equivalents (MET-units).
With larger number of MET-units meaning a more physically active lifestyle
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
|
|
Compliance to the resistance training protocol (As a percentage of 36 planned sessions)
Time Frame: Post (1 week following intervention) - N/A
|
Compliance to the resistance training protocol
|
Post (1 week following intervention) - N/A
|
|
Compliance to the supplement protocol (As a percentage of the given amount)
Time Frame: Post (1 week following intervention) - N/A
|
Compliance to the supplement protocol
|
Post (1 week following intervention) - N/A
|
|
Height (cm)
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
Height of participants
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
|
Weight (kg)
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
Weight of participants
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
|
Age (years)
Time Frame: Pre (1 week prior to intervention) intervention - N/A
|
Age of participants
|
Pre (1 week prior to intervention) intervention - N/A
|
|
BMI (body mass index - Height(cm) / weight (kg)^2)
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
body mass index
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
|
Waist circumference (cm)
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
The circumference around the participants' waist at the midway between the lowest rib and the iliac crest at the end of expiration
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
|
Hip circumference(cm)
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
The circumference around the participants' waist at the level of the trochanter major
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
|
Waist-Hip Ratio
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
Calculated as the waist measurement divided by hip measurement (W⁄H)
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
|
Ankle and brachial index
Time Frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
The ratio between systolic and diastolic blood pressure between measurements of the ankle and brachii
|
Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 10 minutes for all anthropometric measurements
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Diagnostic Techniques and Procedures
- Diagnosis
- Physical Therapy Modalities
- Inorganic Chemicals
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Oxides
- Oxygen Compounds
- Physical Conditioning, Human
- Exercise
- Minerals
- Physical Examination
- Silicon Compounds
- Resistance Training
- Muscle Strength
- Silicon Dioxide
Other Study ID Numbers
- 7260992052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Composition
-
Efforia, IncRecruiting
-
Dynamical Business and Science Society - DBSS International...Universidad de Córdoba; CES University; ARTHROS Centro de Fisioterapia y EjercicioRecruiting
-
Nova Southeastern UniversityCompleted
-
Centro Universitario de Ciencias de la Salud, MexicoCompleted
-
University of Southern CaliforniaCompleted
-
University of California, San FranciscoHologic, Inc.Completed
-
University of SurreyUnknownBody Composition
-
Texas Woman's UniversityCompleted
-
Efforia, IncRecruiting
-
Efforia, IncRecruiting