Calcium, Dairy, and Body Fat in Adolescents

Obesity Clinical Trial

Official title:

Calcium, Dairy, and Body Fat in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592137
• Other study ID #: DK66108 (completed)
• Secondary ID: 5R01DK066108
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 12, 2010
• Start date: April 2004
• Est. completion date: August 2004

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Energy Metabolism
• Obesity

Intervention

Dietary Supplement:
• C (smoothies based on soy protein containing no additional calcium)
Two smoothies per day based on soy protein containing no additional calcium
• B (smoothies based on soy protein containing calcium)
Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate
• A (smoothies based on dairy protein containing calcium)
Two smoothies daily based on dairy protein containing 650 mg calcium

Locations

Country	Name	City	State
United States	Department of Foods and Nutrition	W. Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	Calcium retention		Two weeks on a controlled diet following one week of equilibration on the same diet	No