Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men

Body Composition Clinical Trial

Official title:

Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061315
• Other study ID #: 7260992052
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Body Composition
• Lean Body Mass
• Muscle Power
• Muscle Strength

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