Calcium, Dairy, and Body Fat in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00592137
First received: December 26, 2007
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.

Condition Intervention
Obesity
Energy Metabolism
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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calcium, Dairy, and Body Fat in Adolescents

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: April 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Two smoothies per day 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)
Two smoothies daily based on soy protein containing 650 mg calcium as calcium carbonate
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)
Two smoothies daily based on dairy protein containing 650 mg calcium

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

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592137

Locations
United States, Indiana
Department of Foods and Nutrition
W. Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Connie Weaver, PHD Department Foods and Nutrition, Purdue University
Study Director: Berdine R Martin, PhD Department Foods and Nutrition, Purdue University
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Weaver/Professor and Head of Department, Department of Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT00592137     History of Changes
Other Study ID Numbers: DK66108 (completed), 5 R01 DK066108
Study First Received: December 26, 2007
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
calcium carbonate
obesity
dairy
energy expenditure

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Calcium Carbonate
Calcium, Dietary
Antacids
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014