Calcium, Dairy, and Body Fat in Adolescents

NCT ID: NCT00592137

Last Updated: 2010-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-08-31

Brief Summary

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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

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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

Conditions

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Obesity Energy Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

C (smoothies based on soy protein containing no additional calcium)

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

B (smoothies based on soy protein containing calcium)

Intervention Type DIETARY_SUPPLEMENT

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

A

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

Group Type ACTIVE_COMPARATOR

A (smoothies based on dairy protein containing calcium)

Intervention Type DIETARY_SUPPLEMENT

Two smoothies daily based on dairy protein containing 650 mg calcium

Interventions

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C (smoothies based on soy protein containing no additional calcium)

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

Intervention Type DIETARY_SUPPLEMENT

B (smoothies based on soy protein containing calcium)

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

Intervention Type DIETARY_SUPPLEMENT

A (smoothies based on dairy protein containing calcium)

Two smoothies daily based on dairy protein containing 650 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Department of Foods and Nutrition, Purdue University

Principal Investigators

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Connie Weaver, PHD

Role: PRINCIPAL_INVESTIGATOR

Department Foods and Nutrition, Purdue University

Berdine R Martin, PhD

Role: STUDY_DIRECTOR

Department Foods and Nutrition, Purdue University

Locations

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Department of Foods and Nutrition

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21918216 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19386746 (View on PubMed)

Other Identifiers

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5R01DK066108

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK66108 (completed)

Identifier Type: -

Identifier Source: org_study_id

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