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

This study has been completed.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas
ClinicalTrials.gov Identifier:
NCT01664702
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Childhood Obesity
Dietary Supplement: Dairy Products
Dietary Supplement: Dairy Servings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Substrate Oxidation in Children in Response to Exercise With High and Low Dairy Intake

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 24hr fat oxidation [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Fat oxidation over a 24 hr period will be measured using whole room indirect calorimetry.


Secondary Outcome Measures:
  • 24hr energy expenditure [ Time Frame: baseline, 7 days after each diet ] [ Designated as safety issue: No ]
    Energy Expenditure over a 24 hr period will be measured using whole room indirect calorimetry.


Enrollment: 24
Study Start Date: January 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recommended dairy diet
Recommended servings of dairy products per day
Dietary Supplement: Dairy Products
See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy
Other Name: Recommended dairy servings per day
Experimental: Low dairy diet
One or fewer dairy servings per day
Dietary Supplement: Dairy Servings
Continue baseline consumption of one or fewer servings of dairy per day
Other Name: One or fewer servings of dairy per day

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.

  Eligibility

Ages Eligible for Study:   10 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664702

Locations
United States, Kansas
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Dairy Management Inc.
Investigators
Principal Investigator: Joseph E Donnelly, EdD Univesity of Kansas
  More Information

No publications provided

Responsible Party: Joseph Donnelly, Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01664702     History of Changes
Other Study ID Numbers: HSCL15253, DMI1096
Study First Received: August 10, 2012
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Dairy
obesity

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014