Adequate Dairy Intake on Weight Change in Girls

NCT ID: NCT01066806

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-09-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

high calcium diet

Group Type: EXPERIMENTAL

counseling on increasing calcium intake

Intervention Type: BEHAVIORAL

The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.

normal calcium diet

Group Type: ACTIVE_COMPARATOR

observation

Intervention Type: OTHER

observe normal dairy intake

Interventions

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.

Intervention Type: BEHAVIORAL

observation

observe normal dairy intake

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Joan Lappe

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan M Lappe, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University, Osteoporosis Research Center

Locations

Creighton University Medical Center, Osteoporosis Research Center

Omaha, Nebraska, United States

Countries

United States

References

Lappe JM, McMahon DJ, Laughlin A, Hanson C, Desmangles JC, Begley M, Schwartz M. The effect of increasing dairy calcium intake of adolescent girls on changes in body fat and weight. Am J Clin Nutr. 2017 May;105(5):1046-1053. doi: 10.3945/ajcn.116.138941. Epub 2017 Mar 15.

Reference Type: DERIVED

PMID: 28298396 (View on PubMed)

Other Identifiers

07-14739

Identifier Type: -

Identifier Source: org_study_id