- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488273
Whey Protein Supplementation and Serum Mineral Status in Elite Endurance and Power Athletes
March 20, 2026 updated by: Monira Aldhahi
Whey Protein Supplementation and Serum Mineral Status in Elite Endurance and Power Athletes: A Two-Month Non-Randomized Open-Label Intervention Study
This study investigates whether 8 weeks of post-training whey protein supplementation (30 g/day) affects serum mineral concentrations (calcium, phosphorus, magnesium, and iron) in elite endurance and power athletes during structured training.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a 10-week non-randomized, open-label intervention study involving elite male track-and-field athletes aged 18-26 years.
Participants are allocated into a whey protein supplementation group or a control group based on convenience allocation.
The intervention consists of daily intake of 30 g whey protein following training sessions over 8 weeks.
Blood samples are collected at baseline and post-intervention to assess serum calcium, phosphorus, magnesium, and iron levels.
The study aims to differentiate supplementation effects from training-induced physiological changes.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tunis, Tunisia
- Training Centers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male elite track-and-field athletes
- Age 18-30 years
- Engaged in structured training program
- No supplement use in past 3 months
Exclusion Criteria:
- Use of nutritional or mineral supplements
- Metabolic or musculoskeletal disorders
- Acute injury affecting performance
- Use of ergogenic aids (e.g., creatine, anabolic agents)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whey Protein Group (WG)
Receives 30 g/day whey protein post-training for 8 weeks
|
Participants in the intervention group consumed 30 g/day of whey protein powder within 30 minutes after training sessions for 8 weeks as part of a structured training program.
The supplement (IronMaxx®, 100% Whey Protein) primarily consisted of whey protein concentrate and provided approximately 24 g of protein per daily dose.
The intervention was administered in an open-label manner without placebo control.
Participants were instructed to maintain their habitual diet and refrain from using additional nutritional supplements during the study period.
Other Names:
|
|
Other: Control Group (CG)
Continues usual training without supplementation
|
Participants continued their usual sport-specific training program for 8 weeks without receiving whey protein or any additional nutritional supplementation.
They were instructed to maintain their habitual diet and avoid initiating any new supplements during the study period.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum mineral concentrations (Calcium, Phosphorus, Magnesium, Iron)
Time Frame: Baseline (Week 1) and Post-Intervention (Week 10)
|
Serum concentrations of calcium, phosphorus, magnesium, and iron will be measured using standardized enzymatic and colorimetric assays from venous blood samples collected at rest.
Measurements will be performed at baseline and after the intervention to assess changes associated with training and whey protein supplementation in elite athletes.
|
Baseline (Week 1) and Post-Intervention (Week 10)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2026
Primary Completion (Actual)
February 26, 2026
Study Completion (Actual)
March 15, 2026
Study Registration Dates
First Submitted
March 17, 2026
First Submitted That Met QC Criteria
March 17, 2026
First Posted (Actual)
March 23, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PNU-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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