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OpenTrials
Completed

NCT Number: NCT00592137

Calcium, Dairy, and Body Fat in Adolescents

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.

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Key information

Conditions

Obesity Body Weight Energy Metabolism Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Foods and Nutrition

West Lafayette, Indiana, 47907, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Two smoothies per day based on soy protein containing no additional calcium

B (smoothies based on soy protein containing calcium)

Dietary Supplement

Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate

A (smoothies based on dairy protein containing calcium)

Dietary Supplement

Two smoothies daily based on dairy protein containing 650 mg calcium

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Calcium retention

    Time frame: Two weeks on a controlled diet following one week of equilibration on the same diet

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

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

Registry information

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jan 11, 2008
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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