NCT06061315

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2024

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

September 13, 2023

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • 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 in total

  • 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

  • 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

  • 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

  • +4 more secondary outcomes

Other Outcomes (14)

  • Dietary intake

    Pre (1 week prior to intervention) and during the intervention period (week 10 if the intervention) - N/A

  • 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

  • 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

  • +11 more other outcomes

Study Arms (2)

Collagen peptide group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

The effects of collagen peptide consumption in combination with resistance training will be tested

Collagen peptide group

The effects of placebo consumption in combination with resistance training will be tested

Placebo group

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

Resistance TrainingSilicon DioxideMuscle Strength

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMineralsInorganic ChemicalsOxidesOxygen CompoundsSilicon CompoundsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A double blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 29, 2023

Study Start

September 15, 2023

Primary Completion

November 23, 2024

Study Completion

November 23, 2024

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations