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临床试验 NCT05537857 针对健康目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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圣地亚哥州立大学Racial/Ethnic in Calcium and Sodium Metabolism 66 青少年 饮食 个性化治疗
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临床试验NCT05537857是一项针对健康的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2023年3月1日，计划招募66名患者。该研究由圣地亚哥州立大学主导，预计于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月18日。
简要概括
The increased interest in personalized nutrition has arisen because scientists are beginning to understand subgroup differences in response to the environment including diet. Some suggest that dietary guidance which promotes milk is racially and ethnically insensitive because of higher prevalence of lactose intolerance/maldigestion in non-white groups. Preliminary evidence in Black and White adolescent girls shows th...显示更多
详细描述
Experimental design: Seventy-six adults aged 18-50 years (19 white, 19 Black, 19 Hispanic, and 19 Asians) will be recruited to complete 16 in each group and tested on two levels of dietary salt (lower = 2300 mg/Na/d and higher = 3700 mg Na/d) in randomized order. The primary outcome measures are fractional calcium absorption and urinary calcium excretion. Secondary outcome measures are urinary sodium excretion and wh...显示更多
官方标题
Racial/Ethnic Differences in Calcium Metabolism in Response to Dietary Sodium
疾病
健康其他研究标识符
- HS-2022-0135
NCT编号
实际开始日期
2023-03-01
最近更新发布
2025-07-18
预计完成日期
2026-12
计划入组人数
66
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性High dietary salt High salt diet will be tested in random order by all participants. | High dietary salt Controlled feeding study that varies in salt content. |
实验性Low Dietary salt Low salt diet will be tested in random order by all participants. | High dietary salt Controlled feeding study that varies in salt content. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Fractional calcium absorption | Calcium isotopic tracer | second day of controlled feeding |
Urinary calcium | 24-hour | Entire controlled feeding period |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
blood and urinary minerals | total calcium, magnesium, sodium and ionized calcium and magnesium | Change between baseline and 48 hours |
blood pressure-both systolic and diastolic | Average of 3 seated readings from automated sphygmomanometer | On Day 3 morning after each 2-day controlled feeding |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Healthy adults age 18-50 years, but not postmenopausal
- 3 of 4 grandparents identified as one of four major racial/ethnic groups
- BMI between 18.5 and 30 AND waist circumference less than or equal to 88 cm for females and 102 cm for males
- No allergy to lactose-free milk.
- Taking vasoactive or calcium metabolism-altering medications (statins, antihypertensives, aspirin, steroids, bisphosphonates, thiazide diuretics, hormone replacement therapy, and antidepressants)
- Had bone fracture within the past 6 months
- Diabetes
- Cance
- Liver disease
- Gastrointestinal disease (e.g.: Crohn's disease, irritable bowel syndrome, malabsorption syndrome)
- Decreased kidney function
- Smoking within the past 12 months before the study.
- Habitually consumption > 1000 mg Ca/d from food or supplements.
圣地亚哥州立大学没有联系数据。
1 位于 1 个国家/地区的研究中心
California
San Diego State University, San Diego, California, 92182, United States