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Substrate Oxidation in Children in Response to High and Low Dairy Intake

NCT ID: NCT01664702

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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

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Childhood Obesity

Keywords

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Dairy obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Recommended dairy diet

Recommended servings of dairy products per day

Group Type EXPERIMENTAL

Dairy Products

Intervention Type DIETARY_SUPPLEMENT

See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy

Low dairy diet

One or fewer dairy servings per day

Group Type EXPERIMENTAL

Dairy Servings

Intervention Type DIETARY_SUPPLEMENT

Continue baseline consumption of one or fewer servings of dairy per day

Interventions

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Dairy Products

See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy

Intervention Type DIETARY_SUPPLEMENT

Dairy Servings

Continue baseline consumption of one or fewer servings of dairy per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Recommended dairy servings per day One or fewer servings of dairy per day

Eligibility Criteria

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Inclusion Criteria

* Must be overweight
* and 10-13 years old
* currently consuming 1 or fewer servings of dairy
* less than 600 mg calcium per day

Exclusion Criteria

* not meeting the above criteria
* must be present for duration of the study
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Management Inc.

INDUSTRY

Sponsor Role collaborator

University of Kansas

OTHER

Sponsor Role lead

Responsible Party

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Joseph Donnelly

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph E Donnelly, EdD

Role: PRINCIPAL_INVESTIGATOR

Univesity of Kansas

Locations

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Energy Balance Lab, The University of Kansas

Lawrence, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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DMI1096

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSCL15253

Identifier Type: -

Identifier Source: org_study_id