Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iván Delgado Enciso, Doctor | Universidad de Colima | Study Director |
| Carmen Alicia Sánchez Ramírez, Doctor | Universidad de Colima | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Medicina Familiar No.19, Instituto Mexicano del Seguro Social | Colima | Centro | 28000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37480922 | Background | 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. | |
| 29317895 |
| Label | URL |
|---|---|
| International Diabetes Federation. (2023). IDF Consensus Worldwide Definition of the Metabolic Syndrome. | View source |
Not provided
At the moment we will not share the information until having preliminary results.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093273 | flocculant protein MO 2.1, Moringa oleifera |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| 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. |
|
| 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 | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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. | This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends |
| 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. |
| 32960218 | 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. |
| 31063434 | 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. |
| 33401950 | 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. |
| 35010932 | 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. |
| 19805654 | 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. |
| 9686693 | 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. |
| 30586774 | 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. |
| World Health Organization. (2023). Obesity and overweight. | View source |
| D003920 |
| Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |