Feasibility, Acceptability, Tolerability, and Potential Health Effects of Microgreen Consumption in Healthy Middle-Aged and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of participants retained
研究概览
简要总结
Microgreens are an emerging horticultural food crop with potential to improve human health. Previous research suggests they have broad consumer acceptance and that the micronutrient and bioactive compound levels are higher than that of their mature counterparts. To date, no studies have explored the feasibility of microgreen consumption, gastrointestinal tolerance of microgreen consumption, or their potential health impacts in humans. Therefore, the overall goal of this study is to explore the feasibility and acceptability of daily microgreen consumption, gastrointestinal tolerability, and potential health impacts of red cabbage and red beet microgreens in healthy middle-aged/older men and postmenopausal women - a population inherently at risk for chronic disease, e.g. cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or postmenopausal
- •Aged 45-70
排除标准
- •Cardiovascular disease, hypertension, diabetes, neuropathy, thrombosis, cancer, gastrointestinal, kidney, liver, lung, or pancreatic disease
- •Taking medication for high cholesterol, triglycerides, or blood sugar, or are taking testosterone medications
- •Blood pressure ≥ 130/80 mm Hg, triglyceride levels > 200 mg/dL, low-density lipoprotein cholesterol levels ≥ 160 mg/dL, total cholesterol levels ≥ 240 mg/dL, and/or hemoglobin A1c ≥ 6.5%
- •Weight change ≥ 3 kg (6.6 lb.) in the past 3 months prior to starting the study, are actively trying to lose weight, or are unwilling to remain weight stable throughout the study
- •Have a BMI less than 18.5 or greater than 30 kg/m2
- •Are not willing to maintain normal eating/drinking and exercise habits over the duration of the study
- •Currently smoke cigarettes or have a history of smoking cigarettes in the past 12 months
- •Taking antibiotics or have taken them within one month of starting the study
- •Binge and/or heavy drinker (>4 drinks on any given occasion and/or >14 drinks/week for men)
- •Have allergies or contraindication to study foods, procedures, or procedure supplies
结局指标
主要结局
Number of participants retained
时间窗: Baseline to 6 weeks
The number of participants retained versus lost to follow-up throughout the entire study
Adherence to the intervention
时间窗: Baseline to 2 weeks
Adherence will be determined for each 2-week microgreen intervention through a daily microgreen consumption log
次要结局
- Gastrointestinal symptom self-assessment(Baseline to 2 weeks)
- Gastrointestinal health(Baseline to 2 weeks)
- Blood pressure(Baseline to 2 weeks)
- Augmentation index(Baseline to 2 weeks)
- Microbiota modulation(Baseline to 2 weeks)
- Acceptability(2-week visit)