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Completed

NCT Number: NCT06061315

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 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).

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Key information

Conditions

Body Composition Lean Body Mass Muscle Power Muscle Strength

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark

Odense, 5000, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Lean body mass (kg)

    Time frame: 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 outcomes

  1. Fat mass (kg)

    Time frame: 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)

    Time frame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - 15-25 minutes in total

    Resting energy expenditure measured with the ventilated hood and indirect calorimetry

  3. 1 Repetition maximum strength (kg)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

  9. Blood sampling

    Time frame: Pre (1week prior to intervention) and post (1 week following intervention. i.e 14weeks after inclusion) intervention - about 3 minutes

    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

Other outcomes

  1. Dietary intake

    Time frame: 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)

    Time frame: 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))

    Time frame: 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))

    Time frame: 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)

    Time frame: 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)

    Time frame: Post (1 week following intervention) - N/A

    Compliance to the supplement protocol

  7. Height (cm)

    Time frame: 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)

    Time frame: 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)

    Time frame: Pre (1 week prior to intervention) intervention - N/A

    Age of participants

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Collagen Research Institute

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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