Effect of Moringa Oleifera Leaf Powder on Fasting Blood Glucose Levels in Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose Level
研究概览
简要总结
The goal of this clinical trial was to learn whether Moringa oleifera leaf powder could lower fasting blood glucose in adults aged 25 to 55 years with prediabetes. It also assessed unwanted health effects during the intervention. The main questions it aimed to answer were:
- Does taking Moringa oleifera leaf powder daily for 90 days lower fasting blood glucose compared with a placebo?
- What unwanted health effects occur while participants take Moringa oleifera leaf powder or placebo?
Researchers compared Moringa oleifera leaf powder with matching placebo capsules that contained no Moringa.
Participants:
- Were randomly assigned to receive Moringa oleifera leaf powder or placebo
- Took six 400-mg capsules daily, as two capsules three times a day after meals, for 90 days
- Measured and recorded fasting blood glucose at baseline and every 3 days during the study
- Reported adherence and any unwanted health effects
详细描述
This was a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted in a primary care setting in Bekasi, Indonesia. The study evaluated the effect of Moringa oleifera leaf powder on fasting blood glucose over 90 days in adults with prediabetes.
Eligible participants were adults aged 25 to 55 years with fasting blood glucose levels of 100-125 mg/dL who had not used oral antidiabetic medication or insulin during the preceding 3 months. After providing informed consent, 114 participants were randomly assigned in a 1:1 ratio to the Moringa oleifera leaf powder group or the placebo group.
Participants in the intervention group received 2,400 mg of Moringa oleifera leaf powder daily as six 400-mg capsules, taken as two capsules three times daily after meals for 90 days. Participants in the control group received matching microcrystalline cellulose placebo capsules according to the same schedule.
Fasting blood glucose was measured at baseline and every 3 days through day 90. The primary objective was to compare the longitudinal pattern of fasting blood glucose between the two groups. Treatment adherence and unwanted health effects were also monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants, care providers, investigators, and outcome assessors were unaware of treatment assignments. Moringa oleifera leaf powder and placebo capsules were matched in appearance, packaging, and administration schedule. Allocation codes were concealed until data collection was completed.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting blood glucose levels of 100-125 mg/dL
- •Who had not received oral antidiabetic medications or insulin within the previous three months
- •Had provided written informed consent
排除标准
- •Individuals with hypertension or other significant comorbid medical conditions
研究组 & 干预措施
Moringa Oleifera Leaf Powder
Participants received 2,400 mg of Moringa oleifera leaf powder daily as six 400-mg capsules, taken as two capsules three times daily after meals for 90 days.
干预措施: Moringa Oleifera Leaf Powder (Dietary Supplement)
Placebo
Participants received six matching microcrystalline cellulose placebo capsules daily, taken as two capsules three times daily after meals for 90 days.
干预措施: Moringa Oleifera Leaf Powder (Dietary Supplement)
结局指标
主要结局
Fasting Blood Glucose Level
时间窗: Baseline and every 3 days through Day 90 (31 time points).
Fasting blood glucose was measured in milligrams per deciliter (mg/dL) using a validated capillary blood glucose monitoring device. Repeated measurements were used to evaluate the fasting blood glucose trajectory and differences between the two treatment groups over the 90-day intervention.
次要结局
未报告次要终点