AzTrials
AzTrials

HealthyNCT06682715

Impact of Nutrition Education and Whey Supplementation on Body Composition and Endurance Performance of Athletes

A study testing whey protein, maltodextrin and nutrition education in people with Healthy, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
whey protein, maltodextrin and nutrition education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 sitePakistan
Study dates
1 Jan 2025to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • University of Veterinary and Animal Sciences Lahore,Pakistan

    Lahore, Punjab Province, 38040

Other trials in Pakistan

About this study

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.
Read the detailed description

Proposed place of work:

  1. Football team players from public universities in Lahore.

Plan of work and methodology adopted:

  • Study design: Experimental
  • Duration of study: 7 weeks
  • Participants recruitment: 20 male football players, aged between 18-30 years.

Intervention plan:

Groups Dose Duration Treatment group(n=15) 24g whey protein 5 weeks Placebo group(n=15) Isocaloric maltodextrin 5 weeks

Subjects:

Participants (n=20) will be recruited after initial consent in which they will be fully informed about all benefits, risks, and discomforts of this investigation. Screening process will include Minimum Age: 18 Years Maximum Age: 30 Years

Inclusion Criteria:

Age range: 18-30 years BMI: 18.5 kg/m² to 30 kg/m² Participation in ≥5 training sessions per week

Exclusion Criteria:

Known allergies to whey Recent history of illnesses, musculoskeletal issues, or metabolic diseases use supplementation/medication

Research layout plan:

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.

Pre and post testing:

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) for maximal oxygen consumption calculation.

Dietary assessment:

3 day food dietary recall will be used initially in the 1st week to assess their dietary protein intake. Based on a dietary analysis, participants will be given a dietary plan (taking into account the resting metabolic rate and total daily physical activity related energy expenditure) and their daily protein needs will be calculated using 1.4g/kg of body weight for each participant.

Nutrition education and supplementation:

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 week 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.

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.

Performance test:

A valid field test to determine maximal oxygen consumption in the public is the Rockport Walk Fitness test. Furthermore, it requires little preparation and can be delivered to big crowds. Participants will be given instructions to abstain from strenuous exercise beginning 24 hours before to Rockport walk/run fitness test. On the day of the exam, they will be instructed to eat a light breakfast and report to the gym for recording after two hours. On the treadmill, participants will be told to walk as quickly as they can for 1 mile. The stopwatch will be used to time how long it takes to finish the test. The heart rate will be assessed pre and post 1 mile walk. Maximal oxygen consumption will be calculated by using equation.

Conditions
Healthy
Being tested
whey protein, maltodextrin, nutrition education
Keywords
athlete, body composition, whey supplementation, endurance performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • nutrition educationBehavioural

    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.

Study groups in NCT06682715
Study groupRoleWhat they receive
whey groupExperimentalThey will be given 24g of whey protein 5 days per week post workout.
Receives: Dietary Supplement: whey protein; Behavioral: nutrition education
maltodextrinPlacebo comparator35g of maltodextrin will be given 5 days per week post workout.
Receives: Dietary Supplement: maltodextrin; Behavioral: nutrition education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 weeks

  2. 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

    Measured: 5 weeks

Secondary outcomes (1)
  1. Change in dietary protein intake measured by 24-hour dietary recall and 3-day food records over the 5-week intervention.

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start1 Jan 2025
  3. Primary completion22 Mar 2025
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
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=9) 24g whey protein 5 weeks Placebo group(n=9) Isocaloric maltodextrin 5 weeks
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682715
Sponsor's protocol ID
Whey Supplementation
Status last verified
Sep 2026
First submitted
1 Nov 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28824296
  • 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.

    PubMed 26842665
  • 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.

    PubMed 29659539
  • 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.

    PubMed 31126159

Questions about this trial

What is this clinical trial studying?

A study testing whey protein, maltodextrin and nutrition education in people with Healthy, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body composition parameters (% fat mass, % fat-free mass, BMI) measured by InBody-270 analyzer over 5 weeks (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682715, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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