Calcium, Dairy, and Body Fat in Adolescents

Not Applicable

Completed

• Conditions: Obesity; Energy Metabolism
• Interventions: Dietary Supplement: C (smoothies based on soy protein containing no additional calcium); Dietary Supplement: B (smoothies based on soy protein containing calcium); Dietary Supplement: A (smoothies based on dairy protein containing calcium)

• Registration Number: NCT00592137
• Lead Sponsor: Purdue University

Brief Summary

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.

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 Timeline

• Study Start: 2004-04
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	C (smoothies based on soy protein containing no additional calcium)	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
B	B (smoothies based on soy protein containing calcium)	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
A	A (smoothies based on dairy protein containing calcium)	During one three week session subjects will receive two smoothies per day based on dairy protein containing 650 mg calcium

Primary Outcome Measures

Name	Time	Method
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.	After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Foods and Nutrition; 🇺🇸 W. Lafayette, Indiana, United States