"Effect of Moringa Oleifera Dehydrated Leaf Powder on the Components of Metabolic Syndrome in Mexican Adults. Double-blind Randomized Clinical Trial. Phase II"
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Colima
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in the prevalence of Metabolic Syndrome
Overview
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.
Detailed Description
- . 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).
- . 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].
- . 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.
- . 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.
- . 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 25 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Change in the prevalence of Metabolic Syndrome
Time Frame: 8 weeks
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.
Secondary Outcomes
- 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 triglycerides 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 non- 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)
- 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 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)
- Compare the effect of total 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)
- 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 glycated hemoglobin 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 LDL-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)
Investigators
CarmenSanchez
Principal Investigator
Universidad de Colima