[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568552":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":29,"studyPopulation":19,"armGroups":30,"interventions":44,"overallOfficials":57,"centralContacts":62,"locations":19,"responsibleParty":72,"collaborators":19,"id":74,"slug":19,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":19,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":19,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":97,"whyStopped":19,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":19},{"fullName":5,"class":6},"University of Veterinary and Animal Sciences, Lahore - Pakistan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"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",[17],{"measure":18,"description":19,"timeFrame":12},"Change in dietary protein intake measured by 24-hour dietary recall and 3-day food records over the 5-week intervention.",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":23,"primaryPurpose":24,"observationalModel":19,"timePerspective":19,"maskingInfo":25},"RANDOMIZED","PARALLEL","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) \u002F harvard step test for maximal oxygen calculation.\n\nSupplemental 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\u002F week.\n\nGroups Dose Duration Treatment group(n=15) 24g whey protein 5 weeks Placebo group(n=15) Isocaloric maltodextrin 5 weeks","BASIC_SCIENCE",{"masking":26,"maskingDescription":19,"whoMasked":27},"SINGLE",[28],"PARTICIPANT","Proposed place of work:\n\nI. Football team players from public universities in Lahore.\n\nPlan of work and methodology adopted:\n\n* Study design: Experimental\n* Duration of study: 7 weeks\n* Participants recruitment: 20 male football players, aged between 18-30 years.\n\nIntervention plan:\n\nGroups Dose Duration Treatment group(n=15) 24g whey protein 5 weeks Placebo group(n=15) Isocaloric maltodextrin 5 weeks\n\nSubjects:\n\nParticipants (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\n\nInclusion Criteria:\n\nAge range: 18-30 years BMI: 18.5 kg\u002Fm² to 30 kg\u002Fm² Participation in ≥5 training sessions per week\n\nExclusion Criteria:\n\nKnown allergies to whey Recent history of illnesses, musculoskeletal issues, or metabolic diseases use supplementation\u002Fmedication\n\nResearch layout plan:\n\nA 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.\n\nPre and post testing:\n\nIn 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.\n\nDietary assessment:\n\n3 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\u002Fkg of body weight for each participant.\n\nNutrition education and supplementation:\n\nNutrition 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\u002FTue-Fri\\] and 1 weekend day \\[Sat\u002FSun\\]) will be submitted by each subject every week.\n\nSupplemental 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\u002F week.\n\nPerformance test:\n\nA 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\u002Frun 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.",[31,38],{"label":32,"type":33,"description":34,"interventionNames":35},"whey group","EXPERIMENTAL","They will be given 24g of whey protein 5 days per week post workout.",[36,37],"Dietary Supplement: whey protein","Behavioral: nutrition education",{"label":39,"type":40,"description":41,"interventionNames":42},"maltodextrin","PLACEBO_COMPARATOR","35g of maltodextrin will be given 5 days per week post workout.",[43,37],"Dietary Supplement: maltodextrin",[45,50,52],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":19},"DIETARY_SUPPLEMENT","whey protein","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\u002Fweek.",[32],{"type":46,"name":39,"description":48,"armGroupLabels":51,"otherNames":19},[39],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":19},"BEHAVIORAL","nutrition education","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\u002FTue-Fri\\] and 1 weekend day \\[Sat\u002FSun\\]) will be submitted by each subject every week.",[39,32],[58],{"name":59,"affiliation":60,"role":61},"waqas ahmad","Associate Professor","STUDY_CHAIR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":19,"email":67},"bareera munir","CONTACT","03368503006","Bareeramunir490@gmail.com",{"name":59,"role":65,"phone":69,"phoneExt":70,"email":71},"+92-42-99211449-50","296","waqas.niaz@uvas.edu.pk",{"type":73,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100568552",false,"NCT06682715","Impact of Nutrition Education and Whey Supplementation on Body Composition and Endurance Performance of Athletes","Inclusion Criteria:\n\n* Age (18-35)Individuals with BMI ranging from 18.5 kg\u002Fm2 to 30 kg\u002Fm2\n* participated in ≥5 training sessions\u002Fweek\n\nExclusion Criteria:\n\n* Individuals who have any known allergies especially whey\n* any recent history of illnesses, musculoskeletal problems, and metabolic diseases",true,"MALE","18 Years","30 Years",{"count":84,"type":85},20,"ESTIMATED","INTERVENTIONAL",[88],"NA","Objectives of study are:\n\n* Examining the influence of nutrition education\u002Fcounseling on overall dietary protein consumption.\n* Change in body composition parameters (body mass in kg, BMI kg\u002Fm2, fat mass(kg), fat free mass(kg), skeletal muscle mass(kg), percent body fat ) measured by InBody-270 analyzer over 5 weeks.\n* Change in maximal oxygen consumption assessed using the Rockport Fitness Test after 5 weeks of supplementation.\n\n  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\u002Fm2, 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.",[91],"Healthy",[93,94,95,96],"athlete","body composition","whey supplementation","endurance performance","NOT_YET_RECRUITING","2024-11-08",{"date":100,"type":101},"2024-11-12","ACTUAL",{"date":103,"type":85},"2025-01-01",{"date":105,"type":85},"2025-04-01",{"name":5,"class":6}]