Body CompositionNCT01190592
Resistance Training With Milk Supplementation in Adolescents
A study testing Resistance Training with Milk Supplementation in Adolescents in people with Body Composition and Cardiovascular Risk Factors, run by University of Kansas at 1 site in United States.
Trial summary
The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk) supervised, progressive RT program with increased daily milk intake in untrained adolescents on measures of body composition and cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Cardiovascular Risk Factors
- What is being tested?
- Resistance Training with Milk Supplementation in Adolescents
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to May 2011
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Effects of Resistance Training With Milk Supplementation on Body Composition in Middle School Children
The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk) supervised, progressive RT program with increased daily milk intake in untrained adolescents on measures of body composition and cardiovascular risk factors. The investigators hypothesize that milk supplementation will produce significantly greater favorable changes in all body composition measures compared with RT + carbohydrate and control.
Read the detailed description
We will recruit 150 healthy, adolescent middle school boys and girls (grades 7 through 9), BMI > 50th percentile < 98th percentile, who will participate in 6 months of supervised resistance training (3 days/wk) and will be randomized to one of 3 groups: RT + milk, RT + isocaloric carbohydrate, RT only (control). Both physical activity and diet outside the study protocol will be carefully monitored. Measurements will be completed at baseline 3 months and upon completion of the training protocol at 6 months.
- Conditions
- Body Composition, Cardiovascular Risk Factors
- Being tested
- Resistance Training with Milk Supplementation in Adolescents
- Keywords
- Resistance training, Body Composition, Cardiovascular Risk factors, Dairy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training with Milk Supplementation in AdolescentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Milk | Experimental | Not described Receives: Other: Resistance Training with Milk Supplementation in Adolescents |
| Juice | Experimental | Not described Receives: Other: Resistance Training with Milk Supplementation in Adolescents |
| Water | Placebo comparator | Not described Receives: Other: Resistance Training with Milk Supplementation in Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA
Measured: 6 months
Secondary outcomes (1)
Blood lipids, glucose, and insulin
Blood samples will be collected for the purpose of measuring triglycerides, total cholesterol, HDL-cholesterol, glucose and insulin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Investigators
- Joseph Donnelly, Ed.D, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190592
- Sponsor's protocol ID
- 11935
- Status last verified
- Jun 2011
- First submitted
- 26 Aug 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training With Milk Supplementation on Body Composition in Middle School Children
- ClinicalTrials.gov ID
- NCT01190592
- Acronym / sponsor ID
- 11935
- Conditions
- Body Composition, Cardiovascular Risk Factors
- Keywords
- Resistance training, Body Composition, Cardiovascular Risk factors, Dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk) supervised, progressive RT program with increased daily milk intake in untrained adolescents on measures of body composition and cardiovascular risk factors. The investigators hypothesize that milk supplementation will produce significantly greater favorable changes in all body composition measures compared with RT + carbohydrate and control.
Detailed description
We will recruit 150 healthy, adolescent middle school boys and girls (grades 7 through 9), BMI > 50th percentile < 98th percentile, who will participate in 6 months of supervised resistance training (3 days/wk) and will be randomized to one of 3 groups: RT + milk, RT + isocaloric carbohydrate, RT only (control). Both physical activity and diet outside the study protocol will be carefully monitored. Measurements will be completed at baseline 3 months and upon completion of the training protocol at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk | Experimental | Other: Resistance Training with Milk Supplementation in Adolescents |
| Juice | Experimental | Other: Resistance Training with Milk Supplementation in Adolescents |
| Water | Placebo comparator | Other: Resistance Training with Milk Supplementation in Adolescents |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training with Milk Supplementation in AdolescentsOn 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. | Other | Juice, Milk, Water |
Primary outcome
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
1 secondary outcome
Blood lipids, glucose, and insulin
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
Related trials for Body Composition
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Active, not recruitingObservational study
Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)
Geriatric Assessment, Advanced Cancer
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Multimodal Assessment of Sarcopenia Using Shear Wave Elastography, Dual-Energy X-ray Absorptiometry, Bioelectrical Impedance Analysis, and Physical Performance Measures
Sacropenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Donnelly, Ed.D principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training with Milk Supplementation in Adolescents in people with Body Composition and Cardiovascular Risk Factors, run by University of Kansas at 1 site in United States.
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 6 inclusion and 9 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 21 Jun 2011. 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 United States. 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?
Body Composition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2011.