NCT07171411

Brief Summary

This study tested whether taking whey protein together with collagen peptides would provide greater benefits for muscle and bone health compared to whey protein alone, collagen alone, or a placebo. Forty healthy, resistance-trained men aged 18-35 years were randomly assigned to one of four groups: (1) whey protein plus collagen (30 g + 10 g/day), (2) whey protein only (30 g/day), (3) collagen only (10 g/day), or (4) placebo (maltodextrin). All participants followed a supervised resistance training program (3 times per week) for 8 weeks. The primary outcome was muscle mass, measured with bioelectrical impedance analysis (BIA). Secondary outcomes included bone mineral density (DXA scans), maximal strength (1RM squat and bench press), and blood markers of bone turnover (P1NP and CTX-I). Results showed that the whey + collagen group achieved the largest improvements in muscle growth, lumbar spine bone mineral density, strength, and favorable changes in bone turnover markers compared to all other groups. No serious side effects were reported, and supplement adherence was very high. These findings suggest that combining whey protein and collagen may be a practical strategy to support muscle and bone adaptation in resistance-trained men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 6, 2025

Last Update Submit

September 6, 2025

Conditions

Keywords

Whey ProteinCollagen PeptidesResistance TrainingMuscle MassBone Mineral DensityBone Turnover BiomarkersStrength TrainingProtein SupplementationHypertrophySports Nutrition

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle Mass (kg, lean body mass by BIA)

    Muscle mass was assessed using bioelectrical impedance analysis (InBody 770). Measurements were conducted under standardized conditions (≥8 h fasted, no exercise or caffeine for ≥12 h, urine specific gravity \<1.020). Values reported as lean body mass (kg). Primary analysis compared changes between Whey + Collagen, Whey only, Collagen only, and Placebo groups after 8 weeks of supplementation combined with resistance training.

    Baseline (week 0) to 8 weeks post-intervention

Secondary Outcomes (5)

  • Change in Lumbar Spine Bone Mineral Density (BMD)

    Baseline to 8 weeks

  • Change in Femoral Neck Bone Mineral Density (BMD)

    Baseline to 8 weeks

  • Change in Squat Strength (1RM)

    Baseline to 8 weeks

  • Change in Bench Press Strength (1RM)

    Baseline to 8 weeks

  • Change in Procollagen Type I N-Terminal Propeptide (P1NP)

    Baseline to 8 weeks

Study Arms (4)

Whey Protein + Collagen (WP+C)

EXPERIMENTAL

Participants received 30 g/day whey protein isolate plus 10 g/day type I \& III collagen peptides, split into two daily doses (morning and post-exercise or at same time on rest days). Supplements were packaged in identical sachets.

Dietary Supplement: Whey Protein + Collagen

Whey Protein Only (WP)

ACTIVE COMPARATOR

Participants received 30 g/day whey protein isolate, split into two daily doses. Packaged identically to other interventions to maintain blinding.

Dietary Supplement: Whey Protein

Collagen Only (C)

ACTIVE COMPARATOR

Participants received 10 g/day type I \& III collagen peptides, split into two daily doses. Identical packaging ensured blinding.

Dietary Supplement: Collagen Peptides

Placebo (P)

PLACEBO COMPARATOR

Participants received 10 g/day maltodextrin (isocaloric with protein groups), provided in identical sachets to ensure blinding.

Other: Maltodextrin (Placebo)

Interventions

Whey Protein + CollagenDIETARY_SUPPLEMENT

Participants consumed 30 g/day whey protein isolate (Optimum Nutrition) combined with 10 g/day type I \& III collagen peptides (Vital Proteins). Supplements were provided as single-dose sachets, identical in appearance, and taken twice daily (morning and post-exercise or same time on rest days) for 8 weeks.

Whey Protein + Collagen (WP+C)
Whey ProteinDIETARY_SUPPLEMENT

Participants consumed 30 g/day whey protein isolate (Optimum Nutrition), in identical sachets, taken twice daily for 8 weeks.

Whey Protein Only (WP)
Collagen PeptidesDIETARY_SUPPLEMENT

Participants consumed 10 g/day type I \& III collagen peptides (Vital Proteins), in identical sachets, taken twice daily for 8 weeks.

Collagen Only (C)

Participants consumed 10 g/day maltodextrin powder (isocaloric to protein supplements), packaged identically, taken twice daily for 8 weeks.

Placebo (P)

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male participants aged 18-35 years
  • At least 1 year of consistent resistance training experience (≥3 sessions per week, targeting major muscle groups)
  • Healthy, with no history of musculoskeletal, metabolic, or cardiovascular disorders
  • No current or recent (\<6 months) use of anabolic steroids, growth hormones, or performance-enhancing substances
  • Non-smoker and no habitual use of anti-inflammatory medications
  • Able and willing to comply with supplementation and supervised training program
  • Provided written informed consent

You may not qualify if:

  • Participation in similar supplementation studies in the past 6 months
  • Recent fractures or surgeries affecting musculoskeletal health (\<6 months)
  • Known allergy or intolerance to dairy proteins or collagen supplements
  • Inability to attend scheduled supervised resistance training sessions
  • Non-adherence to dietary control requirements (e.g., use of additional protein/creatine supplements during study)
  • Any condition deemed by investigators to interfere with study compliance or safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Etlik, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertrophy

Interventions

Whey ProteinsCollagenmaltodextrin

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind design extended to all relevant parties. Supplements were provided in identical, opaque sachets to ensure concealment. Randomization sequence was managed by an independent statistician not involved in data collection or analysis. Participants, trainers, investigators, and outcome assessors remained blinded to group assignments until completion of analyses.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned into one of four parallel groups (Whey + Collagen, Whey only, Collagen only, Placebo). Each group received its allocated supplementation daily for 8 weeks in combination with a standardized resistance training program. Groups were followed concurrently with no crossover.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2025

First Posted

September 12, 2025

Study Start

January 3, 2024

Primary Completion

March 10, 2024

Study Completion

April 10, 2024

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that support the findings of this study will be made available to qualified researchers upon reasonable request from the corresponding author. Requests will require approval by the Islamic Azad University Institutional Review Board to ensure compliance with ethical and data protection regulations. Supporting documents such as the study protocol and statistical analysis plan will also be available. Data will be shared beginning 6 months after publication of the study results and remain accessible for 5 years.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
De-identified IPD, study protocol, and statistical analysis plan will be available starting 6 months after publication of the trial results. Data will remain available for a period of 5 years thereafter.
Access Criteria
Qualified academic and clinical researchers may request access to de-identified participant data, along with the study protocol and statistical analysis plan. Requests must be submitted in writing to the corresponding author and will be reviewed by the research team in consultation with the Institutional Review Board. Access will be granted for scientifically valid proposals. Data will be shared through secure transfer methods in compliance with data protection regulations.
More information

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