Calcium, Dairy, and Body Fat in Adolescents

Sponsor

Purdue University (Other)

Overall Status

Completed

CT.gov ID

NCT00592137

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Energy Metabolism	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)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Calcium, Dairy, and Body Fat in Adolescents

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Foods and Nutrition	W. Lafayette	Indiana	United States	47907

Sponsors and Collaborators

Purdue University
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