Clinical trial NCT06061315: Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
Official title: Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Lean Body Mass
Muscle Strength
Muscle Power
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: CRI Collagen Research Institute GmbH
First posted: 2023-09-29
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double blinded randomized controlled trial
Primary purpose: OTHER

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 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).

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. Additionally, blood samples will be taken to ensure health and training eligibility and safety.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Lean body mass (kg)
timeFrame: 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 outcomes:
measure: Fat mass (kg)
timeFrame: 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
measure: Resting energy expenditure (kcal pr. day)
timeFrame: 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
measure: 1 Repetition maximum strength (kg)
timeFrame: 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
measure: Maximal isometric knee extensor force (Nm)
timeFrame: 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
measure: Rate of force development (Nm/sec)
timeFrame: 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
measure: Knee extensor power (W)
timeFrame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 15 minutes
measure: Sit to stand
timeFrame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 3 minutes
measure: Full body bone mineral density (g/cm^2)
timeFrame: 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
Other outcomes:
measure: Dietary intake
timeFrame: Pre (1 week prior to intervention) and during the intervention period (week 10 if the intervention) - N/A
measure: Systolic and diastolic of the ankle and brachii (mm/Hg)
timeFrame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 3 minutes
measure: Questionnaires about health status (36-Item Short Form Survey (SF-36))
timeFrame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
measure: Questionnaires about physical activity level (The Short questionnaire to Assess Health-enhancing physical activity (SQUASH))
timeFrame: Pre (1 week prior to intervention) and post (1 week following intervention. i.e 14 weeks after inclusion) intervention - about 5 minutes
measure: Compliance to the resistance training protocol (As a percentage of 36 planned sessions)
timeFrame: Post (1 week following intervention) - N/A
measure: Compliance to the supplement protocol (As a percentage of the given amount)
timeFrame: Post (1 week following intervention) - N/A
measure: Height (cm)
timeFrame: 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
measure: Weight (kg)
timeFrame: 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
measure: Age (years)
timeFrame: Pre (1 week prior to intervention) intervention - N/A
measure: BMI (body mass index - Height(cm) / weight (kg)^2)
timeFrame: 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
measure: Waist circumference (cm)
timeFrame: 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
measure: Hip circumference(cm)
timeFrame: 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
measure: Waist-Hip Ratio
timeFrame: 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
measure: Ankle and brachial index
timeFrame: 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
Locations:
city: Odense
country: Denmark
facility: The Department of Sports Science and Clinical Biomechanics at University of Southern Denmark
Study officials:
References: