Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
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| City: |
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Omaha |
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Nebraska |
| Zip Code: |
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68131 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01066806 |
| Primary Contact: |
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Principal Investigator
Joan M Lappe, PhD
Creighton University, Osteoporosis Research Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Omaha, Nebraska 68131
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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