Calcium, Dairy, and Body Fat in Adolescents

January 12, 2010 updated by: Purdue University

Lifestyle choices,including diet,are conducive to healthy body weights in children. Dairy products and calcium supplementation have been associated with moderation of body weight and body fat. This study was designed to test the following hypotheses with overweight and obese adolescents consuming a controlled diet:

  • Dietary calcium supplementation as calcium carbonate or dairy calcium modulates energy balance in adolescents.
  • Increased calcium in the diet of adolescents will increase fecal fat excretion and thereby decrease fat absorption.
  • Calcium and dairy product supplementation will increase lipid oxidation resulting in an increase in energy expenditure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will consume a controlled diet containing 800 mg calcium for two three week periods. During one period they will also receive a frozen ice cream like product (smoothie) twice a day based on soy protein that contains no additional calcium. During the other period they will receive a similar product twice a day based on either dairy protein that contains 650 mg calcium or based on soy protein that contains 650 mg calcium as calcium carbonate

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • W. Lafayette, Indiana, United States, 47907
        • Department of Foods and Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over weight (>85th percentile BMI for age)

Exclusion Criteria:

  • > 180% of ideal body weight for height
  • Malabsorptive disorders
  • Bone disease
  • Liver disease
  • Kidney disease
  • Anemia
  • Smoking or illegal drugs
  • Oral contraceptives
  • Pregnancy
  • Medications that influence calcium metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: C
During one three week session of a controlled diet subjects will receive a smoothie based on soy protein two times per day that does not contain any additional calcium
Dietary supplement: C (smoothies based on soy protein containing no additional calcium)
Two smoothies per day based on soy protein containing no additional calcium
Active Comparator: B
During one three week period half of the participants will receive two smoothies per day based on soy protein that contain 650 mg Ca as calcium carbonate
Dietary supplement: B (smoothies based on soy protein containing calcium)
Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate
Active Comparator: A
During one three week session subjects will receive two smoothies per day based on dairy protein containing 650 mg calcium
Dietary supplement: A (smoothies based on dairy protein containing calcium)
Two smoothies daily based on dairy protein containing 650 mg calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Energy balance will be calculated by quantitating the kilocalories represented by the following components: dietary intake, excreta, physical activity, resting energy expenditure, thermic effect of food, and thermogenesis.
Time Frame: After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period.
After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period.

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum biochemical measures of calcium metabolism (PTH, Vitamin D, and calcium)
Time Frame: Serial meausures over a 10 hour period following a meal containing calcium from the placebo, dairy or calcium carbonate supplement
Serial meausures over a 10 hour period following a meal containing calcium from the placebo, dairy or calcium carbonate supplement
Calcium retention
Time Frame: Two weeks on a controlled diet following one week of equilibration on the same diet
Two weeks on a controlled diet following one week of equilibration on the same diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Connie Weaver, PHD, Department Foods and Nutrition, Purdue University
  • Study Director: Berdine R Martin, PhD, Department Foods and Nutrition, Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK66108 (completed)
  • 5R01DK066108 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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