Body Composition Clinical Trial
Official title:
Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
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 plasma lipid profile 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).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | CRI Collagen Research Institute GmbH |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dietary intake | 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 | |
Other | Systolic and diastolic of the ankle and brachii (mm/Hg) | 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 | |
Other | Questionnaires about health status (36-Item Short Form Survey (SF-36)) | 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 | |
Other | Questionnaires about physical activity level (The Short questionnaire to Assess Health-enhancing physical activity (SQUASH)) | 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 | |
Other | Compliance to the resistance training protocol (As a percentage of 36 planned sessions) | Compliance to the resistance training protocol | Post (1 week following intervention) - N/A | |
Other | Compliance to the supplement protocol (As a percentage of the given amount) | Compliance to the supplement protocol | Post (1 week following intervention) - N/A | |
Other | Height (cm) | 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 | |
Other | Weight (kg) | 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 | |
Other | Age (years) | Age of participants | Pre (1 week prior to intervention) intervention - N/A | |
Other | BMI (body mass index - Height(cm) / weight (kg)^2) | 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 | |
Other | Waist circumference (cm) | 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 | |
Other | Hip circumference(cm) | 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 | |
Other | Waist-Hip Ratio | 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 | |
Other | Ankle and brachial index | 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 | |
Primary | 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 | Fat mass (kg) | 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 | |
Secondary | Resting energy expenditure (kcal pr. day) | 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 for all dxa-measurements | |
Secondary | 1 Repetition maximum strength (kg) | 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 | |
Secondary | Maximal isometric knee extensor force (Nm) | 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 | |
Secondary | 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 | 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 | |
Secondary | Knee extensor power (W) | 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 | |
Secondary | Sit to stand | 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 | |
Secondary | Full body bone mineral density (g/cm^2) | 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 |
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