Clinical trial NCT00592137: Calcium, Dairy, and Body Fat in Adolescents
Official title: Calcium, Dairy, and Body Fat in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Energy Metabolism
Keywords: calcium carbonate
obesity
dairy
energy expenditure
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-01-11
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period.
Secondary outcomes:
measure: Serum biochemical measures of calcium metabolism (PTH, Vitamin D, and calcium)
timeFrame: Serial meausures over a 10 hour period following a meal containing calcium from the placebo, dairy or calcium carbonate supplement
measure: Calcium retention
timeFrame: Two weeks on a controlled diet following one week of equilibration on the same diet
Other outcomes:
Locations:
city: W. Lafayette
country: United States
facility: Department of Foods and Nutrition
state: Indiana
Study officials:
affiliation: Department Foods and Nutrition, Purdue University
name: Connie Weaver, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department Foods and Nutrition, Purdue University
name: Berdine R Martin, PhD
role: STUDY_DIRECTOR
References:
citation: Weaver CM, Campbell WW, Teegarden D, Craig BA, Martin BR, Singh R, Braun MM, Apolzan JW, Hannon TS, Schoeller DA, DiMeglio LA, Hickey Y, Peacock M. Calcium, dairy products, and energy balance in overweight adolescents: a controlled trial. Am J Clin Nutr. 2011 Nov;94(5):1163-70. doi: 10.3945/ajcn.110.010264. Epub 2011 Sep 14.
citation: 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. doi: 10.3945/ajcn.2008.26752. Epub 2009 Apr 22.