Effect of Moringa Oleifera Infusion on Health

NCT04314258 | Unknown DMC

• 1 other identifier: UOM002
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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 \[BSc (Hons) Medical Science Student\].
2. 2.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 \[Master of Public Health Students\].
3. 3.To compare the effect of the Moringa tea consumption on lipid profiles of both healthy and hyperglycemic participants \[Master of Public Health Students\].
4. 4.To evaluate the effects of Moringa oleifera Lam leaves on blood anti-oxidant status \[BSc (Hons) Nutritional Sciences Student\].

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  Eight weeks

Secondary Outcomes (1)

• Change in levels of blood anti-oxidants

  Eight weeks

Study Arms (2)

Drinking Moringa oleifera tea

EXPERIMENTAL

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

Drinking plain water

NO INTERVENTION

The control group will receive instructions to consume 200 ml of plain water twice daily for a period of 4 weeks.

Interventions

Moringa oleifera tea DIETARY_SUPPLEMENT

4 grams of Moringa oleifera tea twice daily

Drinking Moringa oleifera tea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Smokers
• 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.

Sponsors & Collaborators

• University of Mauritius: lead

Study Sites (1)

University of Mauritius

Moka, Please Select, 80811, Mauritius

Location

Related Publications (4)

• Bahorun T, Luximon-Ramma A, Neergheen-Bhujun VS, Gunness TK, Googoolye K, Auger C, Crozier A, Aruoma OI. The effect of black tea on risk factors of cardiovascular disease in a normal population. Prev Med. 2012 May;54 Suppl:S98-102. doi: 10.1016/j.ypmed.2011.12.009. Epub 2011 Dec 16.

  PMID: 22198621 BACKGROUND

• Leone A, Bertoli S, Di Lello S, Bassoli A, Ravasenghi S, Borgonovo G, Forlani F, Battezzati A. Effect of Moringa oleifera Leaf Powder on Postprandial Blood Glucose Response: In Vivo Study on Saharawi People Living in Refugee Camps. Nutrients. 2018 Oct 12;10(10):1494. doi: 10.3390/nu10101494.

  PMID: 30322091 BACKGROUND

• Ahmad J, Khan I, Johnson SK, Alam I, Din ZU. Effect of Incorporating Stevia and Moringa in Cookies on Postprandial Glycemia, Appetite, Palatability, and Gastrointestinal Well-Being. J Am Coll Nutr. 2018 Feb;37(2):133-139. doi: 10.1080/07315724.2017.1372821. Epub 2017 Dec 22.

  PMID: 29272206 BACKGROUND

• Kumari, D. J. (2010) 'Hypoglycaemic Effect of Moringa Oleifera and Azadirachta Indica in Type 2 Diabetes Mellitus', The Bioscan, 5(2), p. 4.

  BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie CHAN SUN, PhD

  University of Mauritius

  PRINCIPAL INVESTIGATOR

• Vidushi NEERGHEEN, PhD

  University of Mauritius

  STUDY DIRECTOR

• Abha JODHEEA-JUTTON, MD

  University of Mauritius

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This randomized clinical study will consist of two parallel groups with a crossover design. There will be two arms as follows: 1. Intervention group \[Drinking Moringa tea\] 2. Control group \[Drinking plain water\]. Computer-generated random numbers will be used for simple randomization of subjects to either the experimental or control group. With the cross over design, there will be two phases 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

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 19, 2020
• Study Start: February 10, 2020
• Primary Completion: April 30, 2020
• Study Completion: August 31, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2022-2025
• Access Criteria: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.

Locations

MA (1)