HealthyB3NCT00635583
The Effect of Dairy on Bone Mass and Body Composition in 4th-8th Grade Boys and Girls
A study testing Increased Dairy Consumption in people with Healthy, run by Purdue University at 2 sites in United States.
Trial summary
Building stronger bones during pubertal growth could reduce lifelong fracture risk. This project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th grade boys and girls. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Increased Dairy Consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Jun 2012
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males and females in 4th-8th grade
- Generally healthy
- BMI percentile 5-70% for age or >85% for age
- Baseline calcium intake less than or equal to 800mg/d
Who cannot join
- History of any illness known to affect bone mass accrual (diabetes, inflammatory bowel disease, childhood malignancy).
- A broken bone in the last six months.
- Consume more than 800 mg Calcium/d.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Purdue University
West Lafayette, Indiana, 47907
About this study
Official title: Influence of Dairy on Bone Accrual and Bone Size and Fat and Lean Mass in Early Pubertal Overweight vs. Healthy-weight Boys and Girls
Building stronger bones during pubertal growth could reduce lifelong fracture risk. This project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th grade boys and girls. Half of the girls will receive dairy products to add to their habitual diet (milk, yogurt, and cheese) to equal three products per day, while the other half will remain on their normal diet. All participants will attend four study visits, each 6 months apart. At these visits height, weight, bone density and geometry, and fat and lean mass will be measured. This study aims to show that meeting calcium requirements by eating dairy products builds bigger, stronger bones, and that this effect may be enhanced in overweight boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as well as the mechanisms and predictors of changes in bone mass and size and body composition will also be evaluated.
- Conditions
- Healthy
- Being tested
- Increased Dairy Consumption
- Keywords
- Bone, Dairy Intervention, Girls, Boys, Calcium, Bone Mineralization, Peak Bone Mass, Bone and Bones, Female, Male, Adolescent, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Dairy ConsumptionOther
Also called Prairie Farms Milk, Prairie Farms Yogurt
3 additional servings of dairy (two of which must be milk or yogurt)
- 8 oz milk
- 6 oz yogurt
- 1.5 oz cheese
| Study group | Role | What they receive |
|---|---|---|
| Increased Dairy Consumption | Experimental | Increased Dairy Consumption - Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months. Receives: Other: Increased Dairy Consumption |
| Control | No intervention | This group will not receive the intervention but will continue their normal diet; they will act as the control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone density and geometry as measured with DEXA and pQCT.
Measured: 18 months
Secondary outcomes (1)
Changes in fat and lean body mass as measured with DEXA.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Dairy Management Inc.
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M Weaver, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635583
- Sponsor's protocol ID
- 1482
- Acronym
- B3
- Status last verified
- May 2018
- First submitted
- 6 Mar 2008
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Vogel KA, Martin BR, McCabe LD, Peacock M, Warden SJ, McCabe GP, Weaver CM. The effect of dairy intake on bone mass and body composition in early pubertal girls and boys: a randomized controlled trial. Am J Clin Nutr. 2017 May;105(5):1214-1229. doi: 10.3945/ajcn.116.140418. Epub 2017 Mar 22.
PubMed 28330908
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dairy on Bone Accrual and Bone Size and Fat and Lean Mass in Early Pubertal Overweight vs. Healthy-weight Boys and Girls
- ClinicalTrials.gov ID
- NCT00635583
- Acronym / sponsor ID
- B3 / 1482
- Conditions
- Healthy
- Keywords
- Bone, Dairy Intervention, Girls, Boys, Calcium, Bone Mineralization, Peak Bone Mass, Bone and Bones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Indiana University, Dairy Management Inc.
- Study start
- Mar 2008 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Mar 2008 (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.
Building stronger bones during pubertal growth could reduce lifelong fracture risk. This project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th grade boys and girls. Half of the girls will receive dairy products to add to their habitual diet (milk, yogurt, and cheese) to equal three products per day, while the other half will remain on their normal diet. All participants will attend four study visits, each 6 months apart. At these visits height, weight, bone density and geometry, and fat and lean mass will be measured. This study aims to show that meeting calcium requirements by eating dairy products builds bigger, stronger bones, and that this effect may be enhanced in overweight boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as well as the mechanisms and predictors of changes in bone mass and size and body composition will also be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased Dairy Consumption | Experimental | Other: Increased Dairy ConsumptionIncreased Dairy Consumption - Each subject in this arm will receive three additional servings of dairy to consume each day for 18 months. |
| Control | No intervention | –This group will not receive the intervention but will continue their normal diet; they will act as the control. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females in 4th-8th grade
- Generally healthy
- BMI percentile 5-70% for age or >85% for age
- Baseline calcium intake less than or equal to 800mg/d
Key exclusion criteria (3 listed)
- History of any illness known to affect bone mass accrual (diabetes, inflammatory bowel disease, childhood malignancy).
- A broken bone in the last six months.
- Consume more than 800 mg Calcium/d.
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 |
|---|---|---|
| Increased Dairy ConsumptionAlso: Prairie Farms Milk, Prairie Farms Yogurt3 additional servings of dairy (two of which must be milk or yogurt) * 8 oz milk * 6 oz yogurt * 1.5 oz cheese | Other | Increased Dairy Consumption |
Primary outcome
Changes in bone density and geometry as measured with DEXA and pQCT.
Time frame: 18 months
1 secondary outcome
Changes in fat and lean body mass as measured with DEXA.
Time frame: 18 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 9 May 2018.
- Derived from this study: PubMed 28330908Vogel KA, Martin BR, McCabe LD, Peacock M, Warden SJ, McCabe GP, Weaver CM. The effect of dairy intake on bone mass and body composition in early pubertal girls and boys: a randomized controlled trial. Am J Clin Nutr. 2017 May;105(5):1214-1229. doi: 10.3945/ajcn.116.140418. Epub 2017 Mar 22.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Connie M Weaver, PhD principal investigator
Purdue University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased Dairy Consumption in people with Healthy, run by Purdue University at 2 sites 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 4 inclusion and 3 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Changes in bone density and geometry as measured with DEXA and pQCT. (time frame: 18 months). 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 NCT00635583, which also lists 1 linked publication.
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 9 May 2018.