Efficacy of Optimal Levels of Dietary Dairy on Modulation of Adolescent Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 2
- 主要终点
- percent change in body fat
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
percent change in body fat
时间窗: 1 year
次要结局
未报告次要终点
研究者
Joan Lappe
Professor of Medicine
Creighton University