Randomized Clinical Study Investigating the Effect of Moringa Oleifera Infusion on Bioclinical Parameters of Health
试验速览
- 阶段
- 不适用
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in Triglyceride level
研究概览
简要总结
The study aims at investigating the effects of the consumption of Moringa oleifera Lam leaves on biomedical markers of health among healthy individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L.
The main objectives are as follows:
- To determine the effect of consuming 4 grams of Moringa oleifera Lam leaves infused in 200 ml of hot water twice daily on blood glucose level [BSc (Hons) Medical Science Student].
- To assess the effect of consuming 4 grams of Moringa oleifera Lam leaves infused in 200 ml of hot water twice daily on plasma lipids level [Master of Public Health Students].
- To compare the effect of the Moringa tea consumption on lipid profiles of both healthy and hyperglycemic participants [Master of Public Health Students].
- To evaluate the effects of Moringa oleifera Lam leaves on blood anti-oxidant status [BSc (Hons) Nutritional Sciences Student].
The research work will consist of (1) Experimental intervention: The experimental group will drink Moringa tea; (2) Survey questionnaire, (3) Anthropometric measurements, (4) Blood pressure determination and (5) Blood collections at 15-day intervals during 9 weeks. The blood tests to be performed are as follows: Glucose, HbA1C, Uric acid, C-Protein reactive, Lipid Profile (Total Cholesterol, HDL Cholesterol, Triglycerides), and blood antioxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
详细描述
Study population
120 participants to include 60 healthy individuals and 60 individuals who are hyperglycaemic with a fasting blood glucose equal or greater than 5.5mmol/L will be recruited by means of flyers, posters and mass email by the help of Staff Club of the UoM.
Experimental design
This research work will to be undertaken under the responsibility and coordination of the Applicant who is the Principal Investigator working with two Academic Supervisors for the supervision of the four student projects.
This randomized clinical study will consist of two parallel groups with a crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
A coding system will be used whereby each subject will be attributed a code upon signing the consent form. Only the Principal Investigator assisted by a second investigator will have access to the name-code list.
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
- •Healthy subjects with normal fasting plasma glucose levels
- •Individuals with pre-diabetes condition newly diagnosed
- •Individuals with dyslipidemia
- •Type 2 Diabetes patients taking oral allopathic hypoglycemic agents
排除标准
- •Pregnant women
- •People with alcohol intake >2 standard drinks per day (in line with Bahorun et al. 2012)
- •Patients with any complications of diabetes mellitus
- •Patients on insulin therapy (in line with Leone et al. 2018)
- •Patients with gastro-intestinal, hepatic, cardiovascular, renal or endocrine disorder (other than diabetes mellitus) which can interfere with the absorption, metabolism and excretion of Moringa leaves (in line with Bahorun et al. 2012)
- •Patients on medication for diseases other than diabetes
- •Persons taking botanical extracts
- •People currently on a diet (in line with Ahmad et al. 2018)
- •People having food allergies.
研究组 & 干预措施
Drinking Moringa oleifera tea
The experimental group will drink twice daily 2 tea bags of Moringa oleifera tea (Kanhye brand) infused in 200 ml of hot water (during 5 minutes) for a period of 4 weeks. The locally available Moringa tea with the international certification by ECOCERT France will be used in this study.
干预措施: Moringa oleifera tea (Dietary Supplement)
Drinking plain water
The control group will receive instructions to consume 200 ml of plain water twice daily for a period of 4 weeks.
结局指标
主要结局
Change in Triglyceride level
时间窗: Eight weeks
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Change in blood glucose level
时间窗: Eight weeks
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
Change in Low-density Lipoprotein (LDL) Cholesterol level
时间窗: Eight weeks
Change will be determined as the value at Day 29 with respect to Day 1 for Phase 1 (Four weeks) and for Phase 2 (four weeks)
次要结局
- Change in levels of blood anti-oxidants(Eight weeks)
研究者
MChanSun
Associate Professor
University of Mauritius