Calcium, Dairy, and Body Fat in Adolescents
2 other identifiers
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Apr 2004
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedJanuary 13, 2010
January 1, 2010
4 months
December 26, 2007
January 12, 2010
Conditions
Keywords
Outcome Measures
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.
After equilibration on a controlled diet for one week, measurements will be taken over an additional two week period.
Secondary Outcomes (2)
Serum biochemical measures of calcium metabolism (PTH, Vitamin D, and calcium)
Serial meausures over a 10 hour period following a meal containing calcium from the placebo, dairy or calcium carbonate supplement
Calcium retention
Two weeks on a controlled diet following one week of equilibration on the same diet
Study Arms (3)
C
PLACEBO COMPARATORDuring 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
B
ACTIVE COMPARATORDuring 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
A
ACTIVE COMPARATORDuring one three week session subjects will receive two smoothies per day based on dairy protein containing 650 mg calcium
Interventions
Two smoothies per day based on soy protein containing no additional calcium
Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate
Two smoothies daily based on dairy protein containing 650 mg calcium
Eligibility Criteria
You may qualify if:
- Over weight (\>85th percentile BMI for age)
You may not qualify if:
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Foods and Nutrition
West Lafayette, Indiana, 47907, United States
Related Publications (2)
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.
PMID: 21918216DERIVEDSingh 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.
PMID: 19386746DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Connie Weaver, PHD
Department Foods and Nutrition, Purdue University
- STUDY DIRECTOR
Berdine R Martin, PhD
Department Foods and Nutrition, Purdue University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
April 1, 2004
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
January 13, 2010
Record last verified: 2010-01