Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Carbon isotope values from blood
研究概览
简要总结
In this research study, the investigators will use a novel approach to measure what people eat. The goal is to find out whether stable isotopes that can be measured in blood, hair, and fingernails are better at measuring what people eat than the surveys that are currently used. To meet the goal, the investigators will do three things. First, the investigators will feed study participants known amounts of foods and nutrients. Second, after study participants have eaten the food, the investigators will measure stable isotopes in samples of study participants' blood, hair, and fingernails. Third, the investigators will determine how well these samples reflect what was eaten. The investigators will also give surveys to study participants to determine how well the surveys reflect what was eaten. This will allow the investigators to do a relative comparison of the measurements from isotopes and surveys.
详细描述
This is a controlled feeding study in which the relative validity of stable carbon and nitrogen isotope ratio analysis as a biomarker of dietary intake is compared to controlled feedings and multiple 24-hour recalls. Participants will be randomly assigned to a sequence of diets to be fed on four occasions. Participants will undergo 24 hours of controlled feeding on four non-consecutive days over a month-long period. On the day after feeding, participants will complete 24-hour dietary recalls, and provide blood, hair, and fingernail samples for isotope ratio analyses. The investigators will use a crossover design and the diets will be either high or low in C4 plants (i.e., corn and cane products). A 24-hour urine collection will be done at home during each 24-hour feeding period. Participants will have height and weight measured at the screening visit. Weight will also be measured at each study visit. Additionally, data will be collected via questionnaires administered at each study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double blinding: Participant and person collecting data measurement.
入排标准
- 年龄范围
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women;
- •aged 21 and 74 years;
- •no history of chronic disease and in general good health;
- •able to provide primary study outcome; and
- •willing to tolerate study diets designed for controlled feeding.
排除标准
- •recent dietary changes, restrictions, allergies or preferences;
- •health conditions that require management beyond the scope of the study (e.g. heart failure, kidney disease, liver disease, gastrointestinal disorder);
- •history of drug or alcohol abuse;
- •plans to leave the San Diego area before study completion; and
- •lack of suitability per investigators' discretion.
研究组 & 干预措施
50g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
干预措施: one 24 hr cycle of meals at a 2000 kcal level (Dietary Supplement)
90g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
干预措施: one 24 hr cycle of meals at a 2000 kcal level + one serving sugar sweetened beverage (Dietary Supplement)
130g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
干预措施: one 24 hr cycle of meals at a 2000 kcal level + two servings sugar sweetened beverage (Dietary Supplement)
170g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
干预措施: one 24 hr cycle of meals at a 2000 kcal level + three serving sugar sweetened beverage (Dietary Supplement)
结局指标
主要结局
Carbon isotope values from blood
时间窗: 30 days
The ratio of carbon 13 to carbon 12 in human blood will be determined.
次要结局
- Nitrogen isotope values from fingernails(30 days)
- Carbon isotope values from hair(30 days)
- Nitrogen isotope values from hair(30 days)
- Carbon isotope values from fingernails(30 days)
- Nitrogen isotope values from blood(30 days)
研究者
Cheryl A. Anderson, MPH, PhD
Professor, Interim Chair
University of California, San Diego