Calcium, Dairy, and Body Fat in Adolescents

Purdue University

Status: Completed

Conditions: Energy Metabolism; Obesity

Treatments: Dietary Supplement: B (smoothies based on soy protein containing calcium); Dietary Supplement: C (smoothies based on soy protein containing no additional calcium); Dietary Supplement: A (smoothies based on dairy protein containing calcium)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00592137

5R01DK066108 (U.S. NIH Grant/Contract)

DK66108 (completed)

Details and patient eligibility

About

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.

Full 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

Enrollment: 43 patients

Sex: All

Ages: 12 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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43 participants in 3 patient groups, including a placebo group

C

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: C (smoothies based on soy protein containing no additional calcium)

B

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: B (smoothies based on soy protein containing calcium)

A

Active Comparator group

Description:

During one three week session subjects will receive two smoothies per day based on dairy protein containing 650 mg calcium

Treatment:

Dietary Supplement: A (smoothies based on dairy protein containing calcium)