An interventional study of Moringa oleifera and Placebo in Nutritional and Metabolic Diseases and Metabolic Syndrome, sponsored by Universidad de Colima. Completed at 1 site in Mexico. Open to participants aged 25 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Universidad de Colima · Not applicable, Interventional, and Treatment
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Universidad de Colima is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Compared within Metabolic Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Nutritional and Metabolic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Elimination Criteria
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
Plan to share: No — At the moment we will not share the information until having preliminary results.
Ran from Jan 2023 to primary completion in Jul 2024, 18 months.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 18 months is close to that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Moringa
Universidad de Colima