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Adequate Dairy Intake on Weight Change in Girls (DQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066806
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : September 22, 2016
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Joan Lappe, Creighton University

Brief Summary:

SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: counseling on increasing calcium intake Other: observation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
Study Start Date : July 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight Calcium

Arm Intervention/treatment
Experimental: high calcium diet Behavioral: counseling on increasing calcium intake
The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.

Active Comparator: normal calcium diet Other: observation
observe normal dairy intake

Primary Outcome Measures :
  1. percent change in body fat [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066806

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United States, Nebraska
Creighton University Medical Center, Osteoporosis Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
National Institutes of Health (NIH)
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Principal Investigator: Joan M Lappe, PhD Creighton University, Osteoporosis Research Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Joan Lappe, Professor of Medicine, Creighton University Identifier: NCT01066806    
Other Study ID Numbers: 07-14739
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs