Childhood ObesityNCT01664702
Substrate Oxidation in Children in Response to High and Low Dairy Intake
A study testing Dairy Products and Dairy Servings in people with Childhood Obesity, run by University of Kansas at 1 site in United States.
Trial summary
The investigators propose a randomized trial comparing higher levels of dairy intake compared to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13, overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Dairy Products and Dairy Servings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2005
- 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 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be overweight
- and 10-13 years old
- currently consuming 1 or fewer servings of dairy
- less than 600 mg calcium per day
Who cannot join
- not meeting the above criteria
- must be present for duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Substrate Oxidation in Children in Response to Exercise With High and Low Dairy Intake
The investigators propose a randomized trial comparing higher levels of dairy intake compared to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13, overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each participant will be randomized to either higher or lower levels of dairy intake. A baseline calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet they have been randomized to receive for 6 days and will then have a second calorimeter stay. During this 2nd stay, each participant will continue to receive the diet they were randomized to receive and will achieve a 300 kcal energy deficit through physical activity. The investigators hypothesize that children who receive a 300 kcal energy deficit from the energy expenditure of exercise and receive 3 to 4 servings of dairy products will show greater increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of exercise and receive 1 or fewer servings of dairy products.
Read the detailed description
The study objective was to conduct a randomized clinical trial comparing enhanced levels of dairy consumption to lower levels of dairy consumption during an energy deficit resulting from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2 weeks of wash out. The investigators provided all meals and snacks for the participants during the higher and lower dairy conditions. During the wash out period, participants were instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.
- Conditions
- Childhood Obesity
- Being tested
- Dairy Products, Dairy Servings
- Keywords
- Dairy, obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy ProductsDietary supplement
Also called Recommended dairy servings per day
See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy
Dairy ServingsDietary supplement
Also called One or fewer servings of dairy per day
Continue baseline consumption of one or fewer servings of dairy per day
| Study group | Role | What they receive |
|---|---|---|
| Recommended dairy diet | Experimental | Recommended servings of dairy products per day Receives: Dietary Supplement: Dairy Products |
| Low dairy diet | Experimental | One or fewer dairy servings per day Receives: Dietary Supplement: Dairy Servings |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr fat oxidation
Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.
Measured: 24 hrs
Secondary outcomes (1)
24hr energy expenditure
Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.
Measured: baseline, 7 days after each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas
- Investigators
- Joseph E Donnelly, EdD, Principal investigator, Univesity of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664702
- Sponsor's protocol ID
- HSCL15253
- Other IDs
- DMI1096
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2012
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Oxidation in Children in Response to Exercise With High and Low Dairy Intake
- ClinicalTrials.gov ID
- NCT01664702
- Acronym / sponsor ID
- HSCL15253
- Conditions
- Childhood Obesity
- Keywords
- Dairy, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Aug 2012 (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 propose a randomized trial comparing higher levels of dairy intake compared to lower levels of dairy intake. Participants will be 20 boys and girls, age 10-13, overweight (>85%) who are currently consuming 1 or fewer servings of dairy per day. Each participant will be randomized to either higher or lower levels of dairy intake. A baseline calorimeter stay will determine 24-hour energy needs. Participants will then receive the diet they have been randomized to receive for 6 days and will then have a second calorimeter stay. During this 2nd stay, each participant will continue to receive the diet they were randomized to receive and will achieve a 300 kcal energy deficit through physical activity. The investigators hypothesize that children who receive a 300 kcal energy deficit from the energy expenditure of exercise and receive 3 to 4 servings of dairy products will show greater increases in fat oxidation compared to children who receive a 300 kcal energy expenditure of exercise and receive 1 or fewer servings of dairy products.
Detailed description
The study objective was to conduct a randomized clinical trial comparing enhanced levels of dairy consumption to lower levels of dairy consumption during an energy deficit resulting from 300 kcal of exercise. Participants were 24 sedentary and overweight boys, 13-15 years of age and girls, 12 to 14 years of age, and consuming 1 or fewer servings of dairy and less than 600 mg calcium per day at baseline. Participants were randomly assigned to either higher or lower dairy for 6 days and then crossed over to the opposite treatment subsequent to 2 weeks of wash out. The investigators provided all meals and snacks for the participants during the higher and lower dairy conditions. During the wash out period, participants were instructed to consume their normal diet as assessed at baseline which consisted of 1 or fewer servings of dairy and less than 600 mg calcium. Participants stayed in the calorimeter at baseline, day 7, and day 28 (end of study), after crossover. The calorimeter measured substrate oxidation under the condition of a 300 kcal energy deficit due to exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recommended dairy diet | Experimental | Dietary Supplement: Dairy ProductsRecommended servings of dairy products per day |
| Low dairy diet | Experimental | Dietary Supplement: Dairy ServingsOne or fewer dairy servings per day |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Must be overweight
- and 10-13 years old
- currently consuming 1 or fewer servings of dairy
- less than 600 mg calcium per day
Key exclusion criteria (2 listed)
- not meeting the above criteria
- must be present for duration of the study
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 |
|---|---|---|
| Dairy ProductsAlso: Recommended dairy servings per daySee the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy | Dietary supplement | Recommended dairy diet |
| Dairy ServingsAlso: One or fewer servings of dairy per dayContinue baseline consumption of one or fewer servings of dairy per day | Dietary supplement | Low dairy diet |
Primary outcome
24hr fat oxidation
Time frame: 24 hrs
Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.
1 secondary outcome
24hr energy expenditure
Time frame: baseline, 7 days after each diet
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 14 Aug 2012.
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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 E Donnelly, EdD principal investigator
Univesity 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 Dairy Products and Dairy Servings in people with Childhood Obesity, 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 4 inclusion and 2 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 14 Aug 2012. 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. 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?
24hr fat oxidation (time frame: 24 hrs). 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 14 Aug 2012.