- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190592
Resistance Training With Milk Supplementation in Adolescents
Effects of Resistance Training With Milk Supplementation on Body Composition in Middle School Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Middle school student (Grades 7-9)
- BMI > 50th percentile - < 98th percentile
- No resistance training in the past 6 months.
- Endurance training (running, cycling, swimming, walking for exercise etc) not more than 3 hr per week, as assessed by screening questionnaire.
- Weight stable (+/- 4.5kg) for 3 months prior to intake.
- Willing to be randomized to one of the 3 study groups.
Exclusion criteria:
- Individuals with contraindications based on review of health history by the investigators, including blood pressure, lipid profile, glucose, and insulin, and abnormal values obtained in a 24 item blood panel, such as electrolytes, liver function, etc. These individuals will be referred to their primary care physician for further evaluation and to obtain permission to participate. The following cut-points will be used for cardiovascular and metabolic parameters: dyslipidemia- lipids (cholesterol > 240 mg/L; triglycerides >500 mg/L), hypertension- systolic blood pressure > 140 mmHG or diastolic blood pressure > 90 mmHG, diabetes - fasting glucose from venous plasma fasting glucose > 126 mg/dL.
- Medications that could affect metabolism such as cardiac drugs, thyroid, steroids, insulin, beta blockers, SSRI's, birth control pills, etc.
- Current use of smoking/tobacco products or initiation of smoking/tobacco during the study.
- Eating disorders as determined by screening questionnaire
- Adherence to specialized diet regimes, vegetarian, macrobiotic, etc.
- Food allergies, particularly lactose intolerance.
- Treatment for psychiatric illness of chemical dependency within the previous 6 months.
- Pregnancy or lactation.
- Dietary intake of ≤800 mg calcium and ≤1 servings of milk per day as assessed from 3 -24 hr diet recalls (2 week-days, 1 week-end day) conducted at baseline.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Water
|
On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day. On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day. |
Experimental: Milk
|
On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day. On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day. |
Experimental: Juice
|
On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day. On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition
Time Frame: 6 months
|
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood lipids, glucose, and insulin
Time Frame: 6 months
|
Blood samples will be collected for the purpose of measuring triglycerides, total cholesterol, HDL-cholesterol, glucose and insulin.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Donnelly, Ed.D, University of Kansas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11935 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Composition
-
Nova Southeastern UniversityCompleted
-
Centro Universitario de Ciencias de la Salud, MexicoCompleted
-
University of Southern CaliforniaCompleted
-
University of California, San FranciscoHologic, Inc.Completed
-
University of SurreyUnknownBody Composition
-
Texas Woman's UniversityCompleted
-
Auburn UniversityCompletedBody CompositionUnited States
-
Universidad de ZaragozaUnknown
-
University Hospital, Clermont-FerrandCenter of study in Human Nutrition, INRA, Department of Clinical NutritionCompleted
-
Samsung Medical CenterEnrolling by invitationBody Composition | RemimazolamKorea, Republic of
Clinical Trials on Resistance Training with Milk Supplementation in Adolescents
-
University of AarhusCompleted
-
University of GlasgowCompleted
-
The Jerzy Kukuczka Academy of Physical Education...RecruitingResistance Training | Blood Flow Restriction | Hypoxia, AltitudePoland
-
Truls RaastadUniversity of Copenhagen; University of Padova; TineCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Coordenação de Aperfeiçoamento... and other collaboratorsCompletedProtein Supplementation | Sports NutritionBrazil
-
Dana-Farber Cancer InstituteRecruitingPancreatic CancerUnited States
-
Department of Public Health, DenmarkAarhus University HospitalTerminated
-
KK Women's and Children's HospitalNot yet recruitingGrowth Failure | Very Low Birth Weight Infant | Donor Breast MilkSingapore
-
University of SaskatchewanRecruiting
-
Riphah International UniversityCompletedCOVID-19 PandemicPakistan