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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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1. . Data collection. The patients are being recruited from the medical consultation of the UMF 19 of the IMSS Colima. Participants must have a previous Metabolic Syndrome diagnosis in their medical record (3 or more diagnostic variables according to the 2009 standarization by the 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).
2. . Study groups. 1) Intervention group \[moringa oleifera leaf powder capsules of 0.6 g each\]. 5.5 grams a day divided into 3 doses: 3 capsules of 0.6 g each in the morning, 3 capsules of 0.6 g each in the afternoon, 3 capsules of 0.6 g each at night\]. 2) Placebo group \[5.5 grams of placebo (corn starch) per day divided into 3 doses: 3 capsules of 0.6 g each in the morning, 3 capsules of 0.6 g each in the afternoon, 3 capsules of 0.6 g each at night\].
3. . Randomization and blinding. Computer-generated random numbers were used for simple randomization of subjects to the intervention group (Group A) and placebo group (Group B). Neither the patients nor the principal investigator know to which group subjects belong to (experimental or placebo) until the final results of the study are available.
4. . Preparation of treatment and placebo. For the present study, a sample size of 42 patients was calculated. Each person will consume nine capsules #00 per day (0.63 g each) for a period of 8 weeks. 504 capsules per person will be needed, which is equivalent to a total of 21,168 capsules , of which 10,584 will be Moringa oleifera leaf powder and 10,584 corn starch as an excipient. Due to the nature of the study (double blind), all capsules are black so there is no way to see the contents inside the capsules. Both the raw material (#00 capsules, Moringa oleifera leaf powder (10 kg), starch (10 kg)) and the encapsulation service were provided by the company Encapsuladoras México, based in Chihuahua, Chihuahua. This guarantees a quality product with excellent hygiene standards and precision in the content of the capsules.
5. . Follow-up and adherence to treatment. Both groups (A and B) undergo baseline analyzes before receiving any treatment to ensure that they meet the inclusion criteria and have no metabolic or organ risk. In case of corroborating any lack of control in a patient (monitored with the baseline analysis), the treating physician will make the pertinent adjustment with the medications according to the guidelines and procedures of the HGZ No. 1 of the IMSS Colima. Both groups receive their total capsule doses (504 capsules) divided into two doses with 252 capsules each (one dose for each month). The daily dose contain 5.5 g of Moringa oleifera or placebo (corn starch). Participants are instructed to consume 9 capsules per day divided into 3 doses: 3 capsules in the morning, 3 capsules in the afternoon, 3 capsules in the evening; capsules should be taken before each corresponding meal time (breakfast, lunch, dinner). This goes on for a period of 8 weeks. The delivery of the capsules takes place outside the medical consultation of the Family Medical Unit #19 of the IMSS Colima once the results of the baseline laboratory analyzes are obtained. First month of treatment is given, the patients are summoned again and the following month of treatment is given. To ensure a minimum adherence of 80%, a weekly format is given to the participants together with the capsules. Fort he follow-up, a Whatsapp group was created for motivation and weekly reminders, and phone calls are made once a week to answer questions and find out about follow-up. At the end of their treatment, the participants are summoned again to take final measurements and laboratory analysis.

Conditions

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Nutritional and Metabolic Diseases Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Moringa oleifera

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.

Group Type EXPERIMENTAL

Moringa oleifera

Intervention Type 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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Moringa oleifera

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No