Calcium, Dairy, and Body Fat in Adolescents - Full Text View

Sponsors and Collaborators:	Purdue University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00592137

Purpose

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	Intervention
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)

MedlinePlus related topics: Calcium Dietary Supplements Diets Obesity Obesity in Children

Drug Information available for: Calcium gluconate Calcium carbonate Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Crossover Assignment
Official Title:	Calcium, Dairy, and Body Fat in Adolescents

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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. [ Time Frame: After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Calcium retention [ Time Frame: Two weeks on a controlled diet following one week of equilibration on the same diet ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	April 2004
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
C: Placebo Comparator 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
B: Active Comparator 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
A: Active Comparator 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

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

Eligibility

Ages Eligible for Study:	12 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592137

Locations

United States, Indiana
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

More Information

No publications provided

Responsible Party:	Department of Foods and Nutrition, Purdue University ( Connie Weaver/Professor and Head of Department )
Study ID Numbers:	DK66108, 5 R01 DK066108
Study First Received:	December 26, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00592137 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

calcium carbonate
obesity
dairy
energy expenditure

Study placed in the following topic categories:

Body Weight
Calcium, Dietary
Signs and Symptoms
Obesity
Nutrition Disorders

Antacids
Bone Density Conservation Agents
Overweight
Overnutrition
Calcium Carbonate

Additional relevant MeSH terms:

Obesity
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Overweight
Bone Density Conservation Agents
Calcium Carbonate
Pharmacologic Actions

Body Weight
Signs and Symptoms
Calcium, Dietary
Nutrition Disorders
Overnutrition
Antacids

ClinicalTrials.gov processed this record on May 07, 2009