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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
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.
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.
Unidad de Medicina Familiar No.19, Instituto Mexicano del Seguro Social
Colima, Centro, Mexico
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.
Time frame: 8 weeks
Compare the effect of body mass index (BMI) in the experimental group vs. placebo group
Weight (kg) and height (m) will be combined to report BMI in kg/m\^2. BMI classification kg/m2: Normal range 18.5-24.9 Overweight \> 25 Obesity \> 30 (82). According to the WHO (2023) and the NIH (2022), an absolute reduction of ≥5% from the initial BMI is considered clinically relevant in the general population, ≥10% in people with obesity (BMI ≥30) or comorbidities (diabetes, hypertension) A reduction of ≥5% between the baseline and final measurements will be considered an improvement.
Time frame: 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
Waist circumference for Hispanics \>94 cm in men and \>88 cm in women. A 5-10% reduction from baseline WC improves insulin sensitivity and lipid profile. The formula is calculated as follows: Percentage reduction = \[(baseline value - final value)/ baseline value\] x 100
Time frame: 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
Elevated systolic blood pressure values is \>130 mmHg, and is associated with an increased risk of organ damage and cardiovascular events. A reduction in SBP \>5 mmHg between baseline and final measurement will be considered an improvement. Elevated diastolic blood pressure is \>85 mm/Hg (Antihypertensive drug treatment in a patient with a history of hypertension is an alternative indicator). A reduction in DAS \>3 mm/Hg between baseline and final measurement will be considered improvement.
Time frame: 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
Elevated fasting glucose \>100 mg/dL (Pharmacological treatment for elevated glucose is an alternative indicator). The American Diabetes Association (ADA) and the World Health Organization (WHO) consider a clinically significant improvement in studies with natural interventions (such as Moringa oleifera) when there is a reduction in fasting glucose of ≥20 mg/dL (1.1 mmol/L) in the diabetic population, or ≥10 mg/dL (0.55 mmol/L) in prediabetes. A reduction of ≥10 mg/dL between the baseline and final measurement will be considered an improvement.
Time frame: 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
Adequate values for men: \<40 mg/dL (1.0 mmol/L); for women: \<50 mg/dL (1.3 mmol/L) (Pharmacological treatment for reduced HDL-C is an alternative indicator). According to the AHA/ACC and NLA guidelines (2023), a clinically relevant improvement is considered to be an absolute increase in HDL of ≥5 mg/dL (0.13 mmol/L) in the general population, and ≥10 mg/dL (0.26 mmol/L) in patients with diabetes or metabolic syndrome. An increase of ≥5 mg/dL between the baseline and final measurements will be considered an improvement.
Time frame: 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
Normal values \>150 mg/dL (1.7 mmol/L) (Pharmacological treatment for elevated triglycerides is an alternative indicator). According to the AHA/ACC (2023) and the National Lipid Association (2023), a 20-30% percentage reduction is considered clinically relevant. The formula is calculated as follows: Percent reduction = \[(baseline value - final value)/ baseline value\] x 100
Time frame: 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
Normal values \<200 mg/dL Reduction will be considered of 5-10% from baseline. The formula used is Percent reduction = \[(baseline value - final value)/ baseline value\] x 100 baseline value
Time frame: 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
Normal values \<100 mg/dL. Change is 30-50% reduction from baseline (for statins or combination therapies) . The formula is calculated as follows: Percent reduction = \[(baseline value - final value) / baseline values\] x 100
Time frame: 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
Normal values \<130 mg/dL . Change is 20-30% reduction from baseline. The formula is calculated as follows: Percent reduction = \[(baseline value - final value)/ baseline value\] x 100
Time frame: 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
According to the American Diabetes Association, a diagnosis of type 2 diabetes based on glycated hemoglobin is made when HbA1c is 6.5% or higher, and high risk of this condition is present with an HbA1c of 5.7-6.4%. A reduction in HbA1c of \>0.5% between baseline and final measurement is considered an improvement in diabetic patients. A reduction of ≥0.5% between baseline and final measurement will be considered an improvement.
Time frame: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.