NCT07569770

Brief Summary

The purpose of this 12-week study is to compare the effects of two different post-exercise nutritional supplements on the body composition and exercise performance of elite male university rugby players. Athletes often consume very high amounts of protein to build muscle and recover, but excessive protein intake might pose potential health risks. Study Hypothesis: The researchers hypothesize that a multi-ingredient supplement with a lower total protein content (about 20 grams) will yield comparable or even superior improvements in body composition and physical performance compared to a standard high-dose whey protein supplement (40 grams). Study Design: Twenty elite male college rugby players will be randomly divided into two equal groups. One group will receive the high-dose whey protein, while the other group will receive the lower-dose multi-ingredient supplement (which includes protein, leucine, creatine, red amaranth, and elderberry). Participants will consume their assigned supplement immediately after their training sessions, four times a week for 12 weeks. Assessments: Before and after the 12-week intervention, the researchers will measure the participants' body composition (muscle and fat mass), maximum muscle strength, power, agility, and aerobic endurance. The overall goal is to determine if athletes can achieve optimal performance and muscle growth with a lower, more efficient protein intake strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

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

November 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle Mass

    Muscle mass is assessed using Dual-energy X-ray Absorptiometry (DXA). The change is evaluated by comparing the baseline values to the post-intervention values.

    Baseline and Week 12

Study Arms (2)

High Protein Group

ACTIVE COMPARATOR
Dietary Supplement: Whey Protein Concentrate

Low Protein Multi-Ingredient Group

EXPERIMENTAL
Dietary Supplement: Multi-Ingredient Supplement

Interventions

Whey Protein ConcentrateDIETARY_SUPPLEMENT

Participants consume 40 g of Whey Protein Concentrate (WPC-80), providing 166 kcal, 32 g of protein, 5 g of carbohydrate, and 2 g of fat per serving. It is consumed immediately after training, four times per week for 12 weeks.

High Protein Group
Multi-Ingredient SupplementDIETARY_SUPPLEMENT

Participants consume a multi-ingredient supplement containing approximately 20 g of protein (whey protein fortified with additional leucine and glycine), 30 g of carbohydrates, creatine, red amaranth extract, and elderberry extract (169 kcal). It is consumed immediately after training, four times per week for 12 weeks.

Low Protein Multi-Ingredient Group

Eligibility Criteria

Age19 Years - 26 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Elite rugby athletes in the university team No consumption of performance-enhancing supplements (e.g., creatine, protein supplements, or anabolic-androgenic steroids) one month prior to the study No current medication or major musculoskeletal injuries

You may not qualify if:

  • Vegetarianism Whey protein allergy Body weight fluctuation of more than 10 kg in the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Sciences, University of Taipei

Taipei, 111036, Taiwan

Location

MeSH Terms

Interventions

Whey

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 6, 2026

Study Start

November 30, 2023

Primary Completion

March 30, 2024

Study Completion

July 30, 2024

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

To protect participant privacy, the sharing of individual participant data (IPD) was not included in the informed consent approved by the Institutional Review Board.

Locations