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| Name | Class |
|---|---|
| CRI Collagen Research Institute GmbH | UNKNOWN |
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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained men | Dietary Supplement | The effects of collagen peptide consumption in combination with resistance training will be tested |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Resting energy expenditure (kcal pr. day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Systolic and diastolic of the ankle and brachii (mm/Hg) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark | Odense | 5000 | Denmark |
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A double blinded randomized controlled trial
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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
| Placebo Control intervention: Effect of resistance training in combination with placebo (silicon dioxide), on body composition and muscle strength in untrained men | Dietary Supplement | The effects of placebo consumption in combination with resistance training will be tested |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks 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)) | 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)) | 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) | 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) | Compliance to the supplement protocol | Post (1 week following intervention) - N/A |
| 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 |
| 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 |
| Age (years) | Age of participants | Pre (1 week prior to intervention) intervention - N/A |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D012822 | Silicon Dioxide |
| D053580 | Muscle Strength |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008903 | Minerals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017655 | Silicon Compounds |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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