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NCT Number: NCT06682715

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Proposed place of work:

I. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Whey Protein

Dietary 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

Dietary 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 Education

Behavioral

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.

Primary outcomes

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

    Time frame: 5 weeks

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

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

    Time frame: 5 weeks

    after 5 weeks of supplementation, maximal oxygen consumption will increase

Secondary outcomes

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

    Time frame: 5 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

bareera munir

CONTACT

[email protected]

03368503006

waqas ahmad

CONTACT

[email protected]

+92-42-99211449-50 ext. 296

Sponsors and collaborators

Lead sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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