Nutritional Regulation of Bone - Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Changes in Bone mineral density and quality
研究概览
简要总结
The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.
详细描述
It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover, mass and quality in women, with the hypothesis that higher protein intake will reduce bone turnover and loss, and/or prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years.
Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, or B) weight loss with higher protein intake. A dietitian will provide instructions for a reduced calorie, well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program. Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month. In addition they will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18 to 70 who are undergoing gastric bypass surgery
- •Must live in the geographic vicinity of Rutgers University
排除标准
- •Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease [i.e., heart attack or stroke in the past 6 months., abnormal EKG], active malignancy or cancer therapy within the past year)
- •History of kidney stones
- •Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
- •Participation in other investigational studies during the 12-month study period
- •Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
结局指标
主要结局
Changes in Bone mineral density and quality
时间窗: one year
次要结局
- Changes in serum and urine bone markers, hormones, and proteins(one year)
研究者
Sue A. Shapses, Ph.D., RD
Professor
Rutgers University
