Efficacy and Variability in Plasma Nitrite Levels During Long-term Supplementation With Nitrate Containing Beetroot Juice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- 90 minute plasma Nitrite
研究概览
简要总结
The objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. the investigators were also interested in determining the effect of this intervention on fasting levels of plasma nitrate and nitrite over time. Furthermore, the number of participants classified as "non-responders" was determined based on increases in plasma nitrite achieved using tolerable volumes of beetroot juice by other studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A third party not involved with the conduct of the study provided research staff with the beetroot juice in participant specific coded bottles. The research staff then distributed these coded bottles to the participant. At the end of the trial, the code was revealed for intervention assignment.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Middle and Older (40-80 year-old) men and women
- •Body mass index between 18.5 - 30.0 kg/m2
- •Able to provide own transportation to study testing visits
- •Able to consume study beverages
- •Able to speak and read English
排除标准
- •Tobacco user (smoke or chew), including e-cigarettes
- •Known conditions of: diabetes mellitus (type 1 or 2), atrophic gastritis, hypo- or hyperthyroidism, gout, history of kidney stones, history of hypotension, cardiovascular disease, chronic obstructive pulmonary disease, inflammatory bowel diseases, impaired liver or kidney function
- •Current or recent (last 3 months) treatment for cancer
- •Current use of the following medications: Phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, medication for hypothyroidism, antacid and heartburn medications
结局指标
主要结局
90 minute plasma Nitrite
时间窗: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrite in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage
Fasting Plasma Nitrate
时间窗: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrate in the plasma obtained at the start of each testing visit
Fasting Plasma Nitrite
时间窗: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrite in the plasma obtained at the start of each testing visit
90 minute plasma Nitrate
时间窗: Collected at baseline (week 0), end of week 1, week 2, week 3, week 4, week 8, and week 12
Concentration of nitrate in the plasma obtained 90 minutes following the consumption of the intervention arm's assigned beverage
次要结局
未报告次要终点
研究者
Gary Miller
Professor
Wake Forest University