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

Sponsor
University of Southern Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT06061315
Collaborator
CRI Collagen Research Institute GmbH (Other)
80
1
2
21.5
3.7

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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 and plasma lipid profile

Participants are healthy untrained overweight males (30-60 yrs)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A double blinded randomized controlled trialA double blinded randomized controlled trial
Masking:
Double (Participant, Investigator)
Masking Description:
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
Primary Purpose:
Other
Official Title:
Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
Actual Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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.

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 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.

Dietary Supplement: 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

Outcome Measures

Primary Outcome Measures

  1. Lean body mass (kg) [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)

Secondary Outcome Measures

  1. Fat mass (kg) [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)

  2. Resting energy expenditure (kcal pr. day) [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]

    Resting energy expenditure measured with the ventilated hood and indirect calorimetry

  3. 1 Repetition maximum strength (kg) [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

  4. Maximal isometric knee extensor force (Nm) [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

  5. Rate of force development (Nm/sec) [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

  6. 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]

    Unilateral knee extensor power (W)

  7. Sit to stand [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

  8. Full body bone mineral density (g/cm^2) [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)

Other Outcome Measures

  1. Dietary intake [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

  2. Systolic and diastolic of the ankle and brachii (mm/Hg) [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

  3. Questionnaires about health status (36-Item Short Form Survey (SF-36)) [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

  4. Questionnaires about physical activity level (The Short questionnaire to Assess Health-enhancing physical activity (SQUASH)) [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

  5. Compliance to the resistance training protocol (As a percentage of 36 planned sessions) [Post (1 week following intervention) - N/A]

    Compliance to the resistance training protocol

  6. Compliance to the supplement protocol (As a percentage of the given amount) [Post (1 week following intervention) - N/A]

    Compliance to the supplement protocol

  7. Height (cm) [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

  8. Weight (kg) [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

  9. Age (years) [Pre (1 week prior to intervention) intervention - N/A]

    Age of participants

  10. BMI (body mass index - Height(cm) / weight (kg)^2) [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

  11. Waist circumference (cm) [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

  12. Hip circumference(cm) [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

  13. Waist-Hip Ratio [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)

  14. Ankle and brachial 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]

    The ratio between systolic and diastolic blood pressure between measurements of the ankle and brachii

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark Odense Denmark 5000

Sponsors and Collaborators

  • University of Southern Denmark
  • CRI Collagen Research Institute GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT06061315
Other Study ID Numbers:
  • 7260992052
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023