An interventional study of Moringa oleifera tea in Metabolic Syndrome, sponsored by University of Mauritius. Status unknown at 1 site in Mauritius. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by University of Mauritius · Not applicable, Interventional, and Other
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:
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).
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.
There will be two arms as follows for each group:
Computer-generated random numbers will be used for simple randomization of subjects to either the experimental or control (equal amount of water) groups. Half of the participants will be assigned to the experimental group and the other control (water) for the first 4 weeks during Phase 1.
The experimental group will be provided with Moringa tea bags and instructed to consume twice daily 2 tea bags (4 tea bags equivalent to 8 grams) of Moringa 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.
With the cross over design, there will be two phases for both healthy and hyperglycaemic groups with an interchange of the groups during Phase 1 and 2 as follows:
Four-week Phase 1 - Group A drinking Moringa tea v/s Group B drinking plain water One-week washout Four-week Phase 2 - Group A drinking plain water v/s Group B drinking Moringa tea
The duration of the clinical study will normally be nine weeks with possible extension of four weeks.
Outcome Measurements Baseline data collection Measurements of body weight and blood pressure will be performed. Anthropometric measurements will be taken for each subject: Weight will be measured using an electronic weighing machine, height will be measured using a stadiometer, waist circumference will be measured using a non-stretchable measuring tape. Blood pressure will be measured using a sphygmomanometer.
Blood samples will be drawn by Specialized Nursing Officers from right or left ante-cubital vein of participant after a 12-h overnight fast. Blood tests which will be performed are as follows: Glucose, Lipid profile [Triglycerides, Total Cholesterol and HDL Cholesterol levels (LDL Cholesterol being calculated)], Uric Acid, HbA1C, C-Reactive Protein (hs-CRP) and Blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Fortnight monitoring sessions All participants of the two groups will be monitored on a fortnight basis for body weight, height, waist circumference, blood pressure and specified blood tests. Food intake and physical exercise questionnaires will be collected from participants to determine confounding factors.
[The individual quantity of physical activity, in metabolic equivalent-minutes per week (MET-min/week), will be determined by using validated physical activity questionnaire].
Outcome Measurements Baseline data collection Measurements of body weight and blood pressure will be performed. Anthropometric measurements will be taken for each subject: Weight will be measured using an electronic weighing machine, height will be measured using a stadiometer, waist circumference will be measured using a non-stretchable measuring tape. Blood pressure will be measured using a sphygmomanometer.
Blood samples will be drawn by Specialized Nursing Officers from right or left ante-cubital vein of participant after a 12-h overnight fast. Blood tests which will be performed are as follows: Glucose, Lipid profile [Triglycerides, Total Cholesterol and HDL Cholesterol levels (LDL Cholesterol being calculated)], Uric Acid, HbA1C, C-Reactive Protein (hs-CRP) and Blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity).
Fortnight monitoring sessions All participants of the two groups will be monitored on a fortnight basis for body weight, height, waist circumference, blood pressure and specified blood tests. Food intake and physical exercise questionnaires will be collected from participants to determine confounding factors.
[The individual quantity of physical activity, in metabolic equivalent-minutes per week (MET-min/week), will be determined by using validated physical activity questionnaire].
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 103 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
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Exclusion Criteria:
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.
Dietary Supplement: Moringa oleifera tea
The control group will receive instructions to consume 200 ml of plain water twice daily for a period of 4 weeks.
4 grams of Moringa oleifera tea twice daily
Change in blood glucose level
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)
Time frame: Eight weeks
Change in Low-density Lipoprotein (LDL) Cholesterol level
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)
Time frame: Eight weeks
Change in Triglyceride level
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)
Time frame: Eight weeks
Change in levels of blood anti-oxidants
Levels of blood anti-oxidants (superoxide dismutase, glutathione peroxidase, total blood anti-oxidant capacity) will be monitored every fortnight during the 8-week clinical trial. C-Reactive Protein will also be measured.
Time frame: Eight weeks
Plan to share: Yes — CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 2022-2025
Access criteria: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Mauritius