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Adequate Dairy Intake on Weight Change in Girls (DQ)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joan Lappe, Creighton University
ClinicalTrials.gov Identifier:
NCT01066806
First received: January 19, 2010
Last updated: March 26, 2014
Last verified: March 2014
  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.


Condition Intervention
Obesity
Behavioral: counseling on increasing calcium intake
Other: observation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • percent change in body fat [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 274
Study Start Date: July 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  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: NCT01066806

Locations
United States, Nebraska
Creighton University Medical Center, Osteoporosis Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Joan M Lappe, PhD Creighton University, Osteoporosis Research Center
  More Information

No publications provided

Responsible Party: Joan Lappe, Professor of Medicine, Creighton University
ClinicalTrials.gov Identifier: NCT01066806     History of Changes
Other Study ID Numbers: 07-14739
Study First Received: January 19, 2010
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014