NCT06682715

Brief Summary

Objectives of study are:

  • Examining the influence of nutrition education/counseling on overall dietary protein consumption.
  • Change in body composition parameters (body mass in kg, BMI kg/m2, fat mass(kg), fat free mass(kg), skeletal muscle mass(kg), percent body fat ) measured by InBody-270 analyzer over 5 weeks.
  • Change in maximal oxygen consumption assessed using the Rockport Fitness Test after 5 weeks of supplementation. 20 participants will be randomly assigned to whey or placebo (maltodextrin) group. Pre and post-analysis will be done for body composition, nutrition knowledge and dietary assessment and maximal oxygen consumption. Along with supplementation during week 2-6, individualized nutrition education with food logging will be provided with their programmed training. Changes in body composition (body mass in kg, BMI kg/m2, fat mass(kg), fat free mass(kg), skeletal muscle mass(kg), percent body fat) using In Body Composition Analyzer, maximal oxygen consumption using Rockport Fitness test (1 mile test), protein intake and nutrition knowledge using Nutrition for Sports Knowledge Questionnaire will be assessed.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable healthy

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 1, 2024

Last Update Submit

November 8, 2024

Conditions

Keywords

athletebody compositionwhey supplementationendurance performance

Outcome Measures

Primary Outcomes (2)

  • Change in body composition parameters (% fat mass, % fat-free mass, BMI) measured by InBody-270 analyzer over 5 weeks

    after 5 weeks of supplementation parameters like %fat-mass, %fat-free mass and BMI improve.

    5 weeks

  • Change in maximal oxygen consumption (VO2 max) assessed using the Rockport Fitness Test after 5 weeks of supplementation

    after 5 weeks of supplementation, maximal oxygen consumption will increase

    5 weeks

Secondary Outcomes (1)

  • Change in dietary protein intake measured by 24-hour dietary recall and 3-day food records over the 5-week intervention.

    5 weeks

Study Arms (2)

whey group

EXPERIMENTAL

They will be given 24g of whey protein 5 days per week post workout.

Dietary Supplement: whey proteinBehavioral: nutrition education

maltodextrin

PLACEBO COMPARATOR

35g of maltodextrin will be given 5 days per week post workout.

Dietary Supplement: maltodextrinBehavioral: nutrition education

Interventions

whey proteinDIETARY_SUPPLEMENT

10 out of 20 participants will be randomly added in this group after initial consent in which they will be fully informed about all benefits, risks, and discomforts of this investigation. Screening process will include (1) subjects of age 18-30 years of age; (2) subjects should be free of any recent history of illnesses, musculoskeletal problems, and metabolic diseases; (3) are not using any supplements and medications; and (5) participated in ≥5 training sessions/week.

whey group
maltodextrinDIETARY_SUPPLEMENT

10 out of 20 participants will be randomly added in this group after initial consent in which they will be fully informed about all benefits, risks, and discomforts of this investigation. Screening process will include (1) subjects of age 18-30 years of age; (2) subjects should be free of any recent history of illnesses, musculoskeletal problems, and metabolic diseases; (3) are not using any supplements and medications; and (5) participated in ≥5 training sessions/week.

maltodextrin

Nutrition for sports knowledge questionnaire will be used to assess the pre-nutrition education and post-nutrition education knowledge of athletes. Nutrition education will be given using evidence based nutrition education hand-outs and one-on-one counselling for each athlete in which they will be guided about sources of high biological value protein sources to meet daily protein requirement. Dietary intake will be monitored using 3 day food record method during 2-6 weeks of supplementation. Food logs will be filled out by participants during each weeks to monitor their protein intake. Three food logs (2 weekdays \[Mon-Thurs/Tue-Fri\] and 1 weekend day \[Sat/Sun\]) will be submitted by each subject every week.

maltodextrinwhey group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbiological male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age (18-35)Individuals with BMI ranging from 18.5 kg/m2 to 30 kg/m2
  • participated in ≥5 training sessions/week

You may not qualify if:

  • Individuals who have any known allergies especially whey
  • any recent history of illnesses, musculoskeletal problems, and metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Huang WC, Chang YC, Chen YM, Hsu YJ, Huang CC, Kan NW, Chen SS. Whey Protein Improves Marathon-Induced Injury and Exercise Performance in Elite Track Runners. Int J Med Sci. 2017 Jun 22;14(7):648-654. doi: 10.7150/ijms.19584. eCollection 2017.

  • Taylor LW, Wilborn C, Roberts MD, White A, Dugan K. Eight weeks of pre- and postexercise whey protein supplementation increases lean body mass and improves performance in Division III collegiate female basketball players. Appl Physiol Nutr Metab. 2016 Mar;41(3):249-54. doi: 10.1139/apnm-2015-0463. Epub 2015 Nov 9.

  • Poulios A, Fatouros IG, Mohr M, Draganidis DK, Deli C, Papanikolaou K, Sovatzidis A, Nakopoulou T, Ermidis G, Tzatzakis T, Laschou VC, Georgakouli K, Koulouris A, Tsimeas P, Chatzinikolaou A, Karagounis LG, Batsilas D, Krustrup P, Jamurtas AZ. Post-Game High Protein Intake May Improve Recovery of Football-Specific Performance during a Congested Game Fixture: Results from the PRO-FOOTBALL Study. Nutrients. 2018 Apr 16;10(4):494. doi: 10.3390/nu10040494.

  • Jenner SL, Buckley GL, Belski R, Devlin BL, Forsyth AK. Dietary Intakes of Professional and Semi-Professional Team Sport Athletes Do Not Meet Sport Nutrition Recommendations-A Systematic Literature Review. Nutrients. 2019 May 23;11(5):1160. doi: 10.3390/nu11051160.

MeSH Terms

Interventions

Whey ProteinsmaltodextrinNutrition Assessment

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • waqas ahmad

    Associate Professor

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomized study design will be used to compare the effects of whey vs maltodextrin (placebo) on university football players. The study will be performed during the time period of 7 weeks.In the 1st and 7th week, each participant will have their body composition analysed using InBody-270, USA. Parameters of interest in BIA are fat-mass, fat-free mass, BMI. Nutrition knowledge will be assessed using modified The Nutrition for Sports Knowledge Questionnaire and endurance performance will be assessed using Rockport fitness test (1mile test) / harvard step test for maximal oxygen calculation. Supplemental drinks will include 24g whey protein or iso-caloric amount of maltodextrin for placebo. Participants will be directed to perform their regular training sessions 5-6times/ week. Groups Dose Duration Treatment group(n=15) 24g whey protein 5 weeks Placebo group(n=15) Isocaloric maltodextrin 5 weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 12, 2024

Study Start

January 1, 2025

Primary Completion

March 22, 2025

Study Completion

April 1, 2025

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share