Effect of Moringa Oleifera Dehydrated Leaf Powder on the Components of Metabolic Syndrome in Mexican Adults.

NCT07194577 | Completed DMC

• 1 other identifier: MOD
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The increase in chronic degenerative diseases caused by Metabolic Syndrome (MS) has prompted the search for natural alternatives to develop new medications and to know the mechanism and dosages for their proper use. To date, evidence of the potential use of moringa in the context of metabolic diseases such as diabetes mellitus 2, obesity, and dyslipidemia is available. However, before they can be used as a treatment for metabolic diseases in humans, clinical studies must be carried out to establish the consistency of its medicinal efficacy and the safest modalities of its administration. Objective: To compare the effect of Moringa oleifera dehydrated leaf powder vs a placebo on the components of metabolic syndrome in mexican adults. Material and methods: Double blind randomized clinical trial, phase II. 42 adults diagnosed with MS treated at the family medical consultation of Clinic 19 of the IMSS Colima will be randomly assigned to 2 groups: intervention group (MO powdered leaf capsules, 5.5 grams per day) and placebo group (starch capsules, 5.5 grams per day). The data collected will be weight, height, blood pressure, and waist circumference, and blood tests include glucose, lipid profile \[triglycerides, total cholesterol, HDL cholesterol\], glycosylated hemoglobin. Both groups will be evaluated before starting treatment and 8 weeks later, after completing the treatment. Resources and infrastructure: The laboratory exams will are carried out in HGZ1 no.1 of the IMSS.

Conditions

Nutritional and Metabolic Diseases; Metabolic Syndrome

Keywords

Metabolic syndrome; Moringa oleifera; Diabetes Mellitus type 2; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Change in the prevalence of Metabolic Syndrome

  The change in the proportion of participants meeting the diagnostic criteria for Metabolic Syndrome (according to the NCEP ATP III citeria) from baseline to 8 weeks. The outcome is reported as the difference in prevalence rates between the intervention and placebo groups.

  8 weeks

Secondary Outcomes (10)

• Compare the effect of body mass index (BMI) in the experimental group vs. placebo group

  This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention endsThis measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

• Compare the effect of waist circumference in the experimental group vs. placebo group

  This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

• Compare the effect of blood pressure in the experimental group vs. placebo group

  This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

• Compare the effect of fasting glucose in the experimental group vs. placebo group

  This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

• Compare the effect of HDL-Cholesterol in the experimental group vs. placebo group

  This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

Study Arms (2)

Moringa oleifera

EXPERIMENTAL

To determine if Moringa oleifera dried leaf powder has an effect \* in the components of metabolic syndrome in adults compared to placebo. 5.5 grams of Moringa oleifera Lam leaf powder per day (9 capsules with 0.6 g each) divided into 3 doses - 3 with breakfast, 3 with lunch, 3 with dinner - daily for 8 weeks.

Dietary Supplement: Moringa oleifera

Placebo

PLACEBO COMPARATOR

To determine if Moringa oleifera dried leaf powder has an effect \* in the components of metabolic syndrome in adults compared to placebo. Starch capsules, (9 capsules with 0.6 g each) divided into 3 doses - 3 with breakfast, 3 with lunch, 3 with dinner - daily for 8 weeks.

Dietary Supplement: Placebo

Interventions

Moringa oleifera DIETARY_SUPPLEMENT

5.6 grams of Moringa oleifera Lam dried leaf powder administered orally per day (as nine 0.5 g capsules), divided into three doses (three capsules with breakfast, three with lunch, and three with dinner) for 8 weeks.

Moringa oleifera

Placebo DIETARY_SUPPLEMENT

Starch placebo administered orally per day (as nine 0.5 g capsules), divided into three doses (three capsules with breakfast, three with lunch, and three with dinner) for 8 weeks.

Placebo

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Beneficiaries of the medical consultation of the Instituto Mexicano del Seguro Social (IMSS), Colima
• \- Female and male gender
• People with 3 diagnostic variables of metabolic syndrome according to the standardization of criteria established for the diagnosis of Metabolic Syndrome (2009).
• Patients under treatment for components of metabolic syndrome (dyslipidemia, diabetes, arterial hypertension)
• Signed informed consent

You may not qualify if:

• Conditions that do not allow blood collection
• Patients with metabolic syndrome who currently follow a nutritional plan and/or do exercise
• Pregnant women
• Smokers
• Patients with hypothyroidism and hyperthyroidism, cancer, renal failure and/or liver cirrhosis
• Patients with any complication of diabetes mellitus
• Patients on insulin therapy
• People who take botanical extracts or a multivitamin
• People with food allergies
• Acute infection in progress at the time of blood sample collection
• Patients must not be participating in another study alternately
• Elimination Criteria
• Insufficient, coagulated or hemolyzed serum sample.
• Patients who interrupt treatment or who do not wish to continue.
• Patients who present side effects (nausea, vomiting, diarrhea, stomach pain) or any symptom related to discomfort, allergy or intolerance with the consumption of Moringa oleifera leaf powder that does not disappear in a period of 3 days.

Sponsors & Collaborators

• Universidad de Colima: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Unidad de Medicina Familiar No.19, Instituto Mexicano del Seguro Social

Colima, Centro, 28000, Mexico

Location

Related Publications (9)

• Writing Committee Members; Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2023 Aug 29;82(9):833-955. doi: 10.1016/j.jacc.2023.04.003. Epub 2023 Jul 20.

  PMID: 37480922 BACKGROUND

• Taweerutchana R, Lumlerdkij N, Vannasaeng S, Akarasereenont P, Sriwijitkamol A. Effect of Moringa oleifera Leaf Capsules on Glycemic Control in Therapy-Naive Type 2 Diabetes Patients: A Randomized Placebo Controlled Study. Evid Based Complement Alternat Med. 2017;2017:6581390. doi: 10.1155/2017/6581390. Epub 2017 Nov 28.

  PMID: 29317895 BACKGROUND

• Haber SL, McMahon RP, Barajas J, Hayes AR, Hussein H. Effects of Moringa oleifera in patients with type 2 diabetes. Am J Health Syst Pharm. 2020 Oct 30;77(22):1834-1837. doi: 10.1093/ajhp/zxaa255. No abstract available.

  PMID: 32960218 BACKGROUND

• Chan Sun M, Ruhomally ZB, Boojhawon R, Neergheen-Bhujun VS. Consumption of Moringa oleifera Lam Leaves Lowers Postprandial Blood Pressure. J Am Coll Nutr. 2020 Jan;39(1):54-62. doi: 10.1080/07315724.2019.1608602. Epub 2019 May 7.

  PMID: 31063434 BACKGROUND

• Wang F, Bao Y, Zhang C, Zhan L, Khan W, Siddiqua S, Ahmad S, Capanoglu E, Skalicka-Wozniak K, Zou L, Simal-Gandara J, Cao H, Weng Z, Shen X, Xiao J. Bioactive components and anti-diabetic properties of Moringa oleifera Lam. Crit Rev Food Sci Nutr. 2022;62(14):3873-3897. doi: 10.1080/10408398.2020.1870099. Epub 2021 Jan 6.

  PMID: 33401950 BACKGROUND

• Gomez-Martinez S, Diaz-Prieto LE, Vicente Castro I, Jurado C, Iturmendi N, Martin-Ridaura MC, Calle N, Duenas M, Picon MJ, Marcos A, Nova E. Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes. Nutrients. 2021 Dec 24;14(1):57. doi: 10.3390/nu14010057.

  PMID: 35010932 BACKGROUND

• Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

  PMID: 19805654 BACKGROUND

• Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

  PMID: 9686693 BACKGROUND

• Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

  PMID: 30586774 BACKGROUND

Related Links

• International Diabetes Federation. (2023). IDF Consensus Worldwide Definition of the Metabolic Syndrome.
• World Health Organization. (2023). Obesity and overweight.

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Metabolic Syndrome; Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

flocculant protein MO 2.1, Moringa oleifera

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• Iván Delgado Enciso, Doctor

  Universidad de Colima

  STUDY DIRECTOR

• Carmen Alicia Sánchez Ramírez, Doctor

  Universidad de Colima

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Computer-generated random numbers will be used for simple randomization of subjects to the intervention group and placebo group, which will be performed by someone unrelated to the investigation and provided to the principal investigator in closed envelopes with 2 different categories (A or B), so that the principal investigator does not know the group to which the study subjects belong. Likewise, patients will recieve their treatment marked as A or B, but will not know which group they belong to (experimental or placebo) until the final results of the study are available.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 42 adults diagnosed with metabolic syndrome will be randomly assigned to either the intervention group or the placebo group. The data collected will be weight, height, blood pressure, and waist circumference, and blood tests include glucose, lipid profile \[triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol\], and glycosylated hemoglobin. Both groups will be evaluated before starting treatment and 8 weeks later, after completing the treatment.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: September 26, 2025
• Study Start: January 5, 2023
• Primary Completion: July 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)