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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06061315
Other study ID # 7260992052
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date July 1, 2025

Study information

Verified date September 2023
Source University of Southern Denmark
Contact Jonas S Mathiesen, M.Sc
Phone 26770347
Email JSMathiesen@health.SDU.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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 and plasma lipid profile Participants are healthy untrained overweight males (30-60 yrs)


Recruitment information / eligibility

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.

Study Design


Intervention

Dietary Supplement:
Effect of collagen peptides, in combination with resistance training, on body composition and muscle strength compared to placebo in untrained men
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 men
The effects of placebo consumption in combination with resistance training will be tested

Locations

Country Name City State
Denmark The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark Odense

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark CRI Collagen Research Institute GmbH

Country where clinical trial is conducted

Denmark, 

Outcome

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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