Calcium, Dairy, and Body Fat in Adolescents - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

January 10, 2008

Start Date ^ICMJE

April 2004

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00592137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Calcium, Dairy, and Body Fat in Adolescents

Official Title ^ICMJE

Calcium, Dairy, and Body Fat in Adolescents

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Crossover Assignment

Condition ^ICMJE

Obesity
Energy Metabolism

Intervention ^ICMJE

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)

Study Arms / Comparison Groups

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

Publications *

Singh R, Martin BR, Hickey Y, Teegarden D, Campbell WW, Craig BA, Schoeller DA, Kerr DA, Weaver CM. Comparison of self-reported, measured, metabolizable energy intake with total energy expenditure in overweight teens. Am J Clin Nutr. 2009 Jun;89(6):1744-50. Epub 2009 Apr 22.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2004

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00592137

Responsible Party

Connie Weaver/Professor and Head of Department, Department of Foods and Nutrition, Purdue University

Study ID Numbers ^ICMJE

DK66108, 5 R01 DK066108

Study Sponsor ^ICMJE

Purdue University

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:	Connie Weaver, PHD	Department Foods and Nutrition, Purdue University
Study Director:	Berdine R Martin, PhD	Department Foods and Nutrition, Purdue University

Information Provided By

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

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP