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临床试验/NCT05537857
NCT05537857进行中(未招募)不适用

Racial/Ethnic Differences in Calcium Metabolism in Response to Dietary Sodium

San Diego State University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
66
试验地点
1
主要终点
Fractional calcium absorption

研究概览

简要总结

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 that Blacks retain more calcium and excrete more sodium than white girls on a high sodium diet making Whites more vulnerable to osteoporosis and Blacks more vulnerable to hypertension on high salt diets. Adequate dietary calcium is protective for both groups. This project will compare calcium absorption and calcium and sodium excretion from lactose-free milk as part of a controlled diet on higher (usual Western diet) and lower (recommended) salt intakes in Black, White, Hispanic, and Asian adults.

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 whole blood serum ionized calcium and magnesium concentrations.

Participants will be recruited by poster or by passed out flyers on and near campus, through presentations to organizations where potential participants attend (YMCA, fraternities, churches, etc.), and advertising through newspaper ads, social media, and others. Respondents will be invited for a screening visit at the Exercise and Nutritional Sciences Department to determine eligibility and to sign a consent form.

Eligible participants will have 3 of 4 grandparents self-identified as the racial/ethnic group. They will not have taken any vasoactive or calcium metabolism-altering medications (statins, antihypertensives, aspirin, steroids, bisphosphonates, thiazide diuretics, hormone replacement therapy, and antidepressants), experienced a bone fracture within the past 6 months, had diabetes, cancer, liver disease, gastrointestinal disease (e.g.: Crohn's disease, irritable bowel syndrome, malabsorption syndrome), decreased kidney function, or have smoked cigarettes within the past 12 months before the study. Eligible subjects will also not have had habitually consumed > 1000 mg Ca/d from food or supplements.

Upon providing written consent, applicants will complete a brief questionnaire on medical history, physical activity, and supplement use and a 4-day diet record to assess usual dairy intake as well as nutrients known to influence calcium and sodium metabolism i.e. calcium, sodium, magnesium, protein, fiber. Waist circumference, height, and weight will be measured to determine the body mass index (BMI) and a fasting blood sample will be collected to assess blood biochemistries and metabolomics. A DXA will be performed to determine total body calcium as a covariate.

Enrolled subjects will be randomized to a sequence of 2 treatments of a high (3700 mg sodium) or low (2300 mg sodium) diet for 2-days each separated by a 4-week washout period during which they will consume self-selected diets. All food and beverages will be provided to control for the nutrients known to influence calcium metabolism with salt being the main difference between the periods. Menus will be devised to control for energy, calcium, sodium, macronutrients, and fiber. Portions will be adjusted for energy needs of the participant. They will be asked to discontinue taking any dietary supplements 30 days prior to the study and to abstain from caffeine, alcohol, and strenuous exercise for 24 hours before each test session. Participants will be asked to collect urine for 48 hours to measure sodium, calcium, and magnesium excretion and a stool sample for measuring fecal metabolomics. On the following day. Participants will be asked to abstain from all foods and beverages not provided until the last blood draw. Blood pressure will be measured on the last day of each treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Dietary salt will be varied. Kitchen staff will not be blinded. Foods/diet will be coded so blind to investigators interacting with participants and analytical staff although participants may be able to perceive salty foods.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • 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.

研究组 & 干预措施

High dietary salt

Experimental

High salt diet will be tested in random order by all participants.

干预措施: High dietary salt (Other)

Low Dietary salt

Experimental

Low salt diet will be tested in random order by all participants.

干预措施: High dietary salt (Other)

结局指标

主要结局

Fractional calcium absorption

时间窗: second day of controlled feeding

Calcium isotopic tracer

Urinary calcium

时间窗: Entire controlled feeding period

24-hour

次要结局

  • blood and urinary minerals(Change between baseline and 48 hours)
  • blood pressure-both systolic and diastolic(On Day 3 morning after each 2-day controlled feeding)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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