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Adequate Dairy Intake on Weight Change in Girls - NCT01066806-68131(Clinical Trial 494499)



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City:  Omaha
State:  
NE
Zip Code: 68131
Conditions: Obesity
Purpose: SPECIFIC AIM The aim of this study is to determine the effects of increasing dairy intake to four servings per day on change in percent body fat in post-menarcheal adolescent girls with habitual low calcium intakes. HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.
Study summary:
Criteria: Inclusion Criteria: - Age 13-14 years old (must be this age when consent is signed) - Above the 50th percentile for BMI - Above the 85th percentile for BMI with approval from their primary physician - At least one and one- half years post menarche - Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake. - Willingness to increase dietary calcium (low fat [skim, 1%, 2%] milk or yogurt) for one year Exclusion Criteria: - Menarche prior to age 10 - History of lactose intolerance or milk allergy - Weight >300 pounds - BMI > 97 percentile for age and gender - Pregnancy - Chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been >10 years) - Use of steroids like prednisone, prednisolone, hydrocortisone, Flovent, Advair, or Nasonex - Use of weight reducing medications like Meredia, alli, Dexatrim or Xenical - Use of contraceptives like Yasmin, Ortho Tri-Cyclen, Apri, Aviane or Depo-Provera for any reason, including acne (see inclusive list) - Use of acne medications like Accutane or high dose Vitamin A - Use of ADHD medications like Adderall, Ritalin, Concerta. (Per Dr. Ramaswamy-Straterra OK) (see inclusive list) - Use of seizure medications like Lamictal or Phenobarb (see inclusive list) - Use of anti-depressants like Prozac or Effexor (see inclusive list) - Diagnosed eating disorder - Dieting behavior with weight loss > 10 pounds in the last 3 months (IF YES, consult with Project Manager) - Metal in the skeleton (pins, rods, etc) - Sibling of a child who is or has been on a dietary study in the last 5 years - Total body BMC Z-score below -2.0 at baseline - Participating in other ongoing research protocols
Study is available at: Creighton University Medical Center, Osteoporosis Research Center
Omaha, NE 68131
United States

Primary Contact:
Margaret Begley, RN
Email: margaretbegley@creighton.edu
Phone: 402-280-4578

Secondary Contact:
Joan M Lappe, PhD
Email: jmlappe@creighton.edu
Phone: 402-280-4646
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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