Effect of Regular Consumption of a Symbiotic Yogurt on Calcium Absorption and Bone Health in Young Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Change in calcium absorption
研究概览
简要总结
Prebiotics have been linked to increased calcium absorption in animal and human studies (particularly in adolescents and in premenopausal women). Similarly, probiotics have been found to benefit calcium homeostasis in pregnant women, and to promote bio-mineralization in animal models. The effect of symbiotic on calcium absorption has been tested in rats, but not in human studies. The primary objective of this study is to investigate the effect of daily consumption of a functional symbiotic yogurt containing inulin and Lactobacillus rhamnosus compared to a control yogurt, on calcium absorption in young adult women. A secondary objective is to relate changes in calcium absorption following yogurt consumption, with calcium metabolism, vitamin D status, bone mass, calcium intake and overall composition of habitual diet.
详细描述
A potential strategy to reduce the risk of osteoporosis later in life is to promote optimal bone mass during early adulthood by including in the diet functional foods that maximize the efficiency of calcium absorption. This approach is specially important in women because of their greater risk for osteoporosis than men. In this study, we hypothesized that the daily consumption of a yogurt containing inulin and Lactobacillus rhamnosus (symbiotic yogurt) increases the efficiency of calcium absorption in young adult women when compared to daily consumption of a yogurt of similar composition but without prebiotic or probiotic (control yogurt). Subjects in this study will be randomly assigned to consume daily the symbiotic yogurt or the control yogurt during two 3-week periods with a wash-out period of 3-weeks, in a cross-over design. Calcium absorption will be measured by stable calcium isotope methodology. Bone mass (BMD, BMC) will be measured by dual-Y ray absorptiometry. Serum intact parathyroid hormone, 25-hydroxyvitamin D and dietary intake will be measured by conventional methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Type of yogurt fed is blind for participants and investigators
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ages 18 to 35 years
- •generally healthy
排除标准
- •pregnancy/lactation
- •BMI <18,5 kg/m2
- •BMI> 29 kg/m2
- •metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism
研究组 & 干预措施
functional yogurt
Participants are given the symbiotic yogurt daily (180 ml)
干预措施: yogurt (Dietary Supplement)
control yogurt
Participants are given the control yogurt daily (180 ml)
干预措施: yogurt (Dietary Supplement)
结局指标
主要结局
Change in calcium absorption
时间窗: Day 21 and Day 63
Fractional calcium absorption measured with stable isotopes
次要结局
- Bone mineral content and bone mineral density(Day 1)
- Serum 25(OH) vitamin D(Day 1)
- Dietary calcium intake(Day 1)
研究者
Carmen Marino Donangelo
Professor
Universidad de la Republica