- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01066806
Adequate Dairy Intake on Weight Change in Girls (DQ)
Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
Nebraska
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Omaha, Nebraska, Forente stater, 68131
- Creighton University Medical Center, Osteoporosis Research Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: high calcium diet
|
The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.
|
Aktiv komparator: normal calcium diet
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observe normal dairy intake
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
percent change in body fat
Tidsramme: 1 year
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joan M Lappe, PhD, Creighton University, Osteoporosis Research Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07-14739
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