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CompletedNCT00592137Updated Jan 13, 2010

Calcium, Dairy, and Body Fat in Adolescents

An interventional study of C (smoothies based on soy protein containing no additional calcium) and B (smoothies based on soy protein containing calcium) in Obesity and Energy Metabolism, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2010-01-13.

Sponsored by Purdue University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
12 Years to 15 Years
Sex
All
01

Study 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.
Read the 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

02

Conditions studied

  • Obesity
  • Energy Metabolism

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Keywords

  • calcium carbonate
  • obesity
  • dairy
  • energy expenditure
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 43 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Purdue University is the lead sponsor of 174 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over weight (>85th percentile BMI for age)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Placebo comparator
    C

    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)

  • Active comparator
    B

    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)

  • Active comparator
    A

    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)

Interventions

  • Dietary supplementC (smoothies based on soy protein containing no additional calcium)

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

  • Dietary supplementB (smoothies based on soy protein containing calcium)

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

  • Dietary supplementA (smoothies based on dairy protein containing calcium)

    Two smoothies daily based on dairy protein containing 650 mg calcium

06

What researchers measure

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

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Study locations

1 site
  • Department of Foods and Nutrition
    West Lafayette, Indiana 47907, United States
08

References and documents

Publications

  • 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. PubMed 21918216 ↗
  • 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. PubMed 19386746 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00592137
Lead sponsor
Purdue University
First posted
Jan 11, 2008
Start date
Apr 2004
Primary completion
Aug 2004
Completion
Aug 2004
Last update
Jan 13, 2010

Study contacts

Connie Weaver, PHD
principal investigator · Department Foods and Nutrition, Purdue University
Berdine R Martin, PhD
study director · Department Foods and Nutrition, Purdue University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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