Moringa Powder Acceptability Trial Among Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Consumption
研究概览
简要总结
The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.
详细描述
Moringa is a drought-resistant nutrient-dense tree with high concentrations of anti-inflammatory plant chemicals in its edible leaves and seeds. In preclinical studies Moringa has been shown to improve insulin resistance, dyslipidemia, and high blood pressure. But its effects in humans remain unclear. Moringa (20g leaf powder on two different days) supplementation decreased post-prandial glucose in Saharawi refugees with type 2 diabetes, compared to controls (Leone, et. al., 2018). In a randomized control trial in Spain, Moringa consumed as six daily capsules of dry leaf powder (2.4 g/day) for 12 weeks, significant decreased fasting blood glucose and glycated hemoglobin (HbA1c) among prediabetic subjects (Gomez-Martinez, et. al., 2021).
The investigators are conducting a testing trial of Moringa oleifera leaves, offered as powder, to be added to foods and/or drinks to test safety, acceptability and consumption of it in three different doses: 1 tsp, 2 tsp, and 3 tsp. Study participants will be randomly allocated to one of the three doses.
Among the studies that have been conducted with human subjects (individuals with diabetes), no adverse effects have been reported with whole leaf powder at up to a single dose of 50 g or using 8 g per day dose for 40 days (Stohs & Hartman, 2015).
The outcomes to be measured in this testing trial are the following:
- Consumption (measured by self-report and skin carotenoid level, as a biomarker of consumption of fruits and vegetables)
- Acceptability (measured by rating the taste of the moringa powder when consumed with foods/drinks)
- Safety (measured by self-report of any potential side effects, such as digestive issues due to fiber content) Results from this trial will suggest an acceptable dose in a population not yet diagnosed with a specific disease (e.g. diabetes) and therefore potentially less willing to consume it in doses that could make taste a potential barrier for consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Baseline assessor will reveal the participants group, only after completing the baseline measurements. After provision of corresponding dosage (assignment), the group information will again be covered, per programming in the Excel file.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults (18-65 y old)
- •University of California (UC) Berkeley staff
- •able to communicate in English or Spanish
排除标准
- •UC Berkeley students or academic employees
- •pregnant or lactating individuals
- •individuals who already consume Moringa regularly
- •individuals who have been told that they have diabetes or hypothyroidism
- •individuals who are taking any medication, with the exception of over-the-counter pain medication and contraceptives
- •individuals who follow a medically prescribed diet
研究组 & 干预措施
Moringa Powder - Medium Dose
Group A
干预措施: Moringa Powder - Medium Dose (Other)
Moringa Powder - High Dose
Group B
干预措施: Moringa Powder - High Dose (Other)
Moringa Powder - Low Dose
Group C
干预措施: Moringa Powder - Low Dose (Other)
结局指标
主要结局
Consumption
时间窗: 7 days
Total number of days that moringa powder was consumed
Side effects
时间窗: 7 days
Total number of side effects reported
Acceptability
时间窗: 7 days
Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance
次要结局
- Daily dose consumed(7 days)
