Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile in Prediabetic Patients (NUTRIMOL-DB)

Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile. Nutritional Intervention Study in Prediabetic Patients

Moringa oleifera (MO) is a traditional food in tropical and subtropical areas and has attained a growing interest for its medicinal properties. It's a nutrient-rich vegetable, high in protein and polyphenol content. The MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Dietary supplement: Moringa; Dietary supplement: Placebo

Detailed Description

The tree Moringa oleifera (MO) is a traditional medicinal plant in tropical and subtropical areas, also consumed as food, which is currently expanding worldwide as a protein-rich leafy vegetable and for the medicinal value of its phytochemicals, in particular its glucosinolates. Specifically, MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. In this sense, in vitro and preclinical experiments have shown that MO could potentially reverse some of the pathophysiological manifestation of diabetes and its comorbidities, such as hepatic fat accumulation and insulin resistance, oxidative stress, inflammation and peripheral hyperglycemia. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo. This will be a double-blind, randomized, placebo controlled, parallel group intervention study. Subjects will randomly consume either 6 capsules of dry MO leaves (400 mg dry leaf powder /capsule) or 6 placebo capsules per day during 3 months. The study subjects will provide samples for outcome measurements at three different time points: basal, 6 weeks and 12 weeks of supplementation. Glycaemia and plasma inflammatory and metabolic markers will be measured, as well as the gut microbiota composition.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Institute of Food Science and Technology and Nutrition (ICTAN)-CSIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Prediabetes: HbA1c between 5.7-6.4 % or fasting blood glucose between 100 - 125 mg/dl or impaired glucose tolerance (> 140 mg/dl and < 200 mg/dl two hours post oral challenge).
• No pharmacological treatment prescribed for glycemia control.

Exclusion Criteria:

• Diabetes Mellitus
• Impaired renal function: < 60% Glomerular filtration
• Uncontrolled high blood pressure
• Previous cardiovascular events or coronary disease
• Autoimmune disease
• HIV
• Severe gastrointestinal disease
• Cancer
• Psychiatric illness
• Elevated liver enzymes (x2 normal range)
• Alcohol abuse (higher than 14 and 21 doses/week for women and men, respectively)
• Morbid obesity (BMI>35kg/m2)
• Pregnancy
• Pharmacological treatments that interfere with glucose control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Moringa; Six Moringa oleifera capsules (400 mg dry leaf powder /capsule) consumed daily during 12 weeks. Two capsules consumed with each of the three main meals.	Dietary supplement: Moringa; Leaves of Moringa oleifera from an organic Iberian peninsula cultivar. A single lot was prepared from the same crop. Leaves were dried and ground and encapsulated as a organic dietary supplement. No other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended.
PLACEBO_COMPARATOR: Placebo; Six placebo capsules containing microcrystalline cellulose consumed daily during 12 weeks. Two capsules consumed with each of the three main meals.	Dietary supplement: Placebo; Placebo capsules were indistinguishable from the experimental capsules in material and color (opaque white). Same number of capsules were consumed as in the experimental arm and no other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube	12 weeks
Glycated hemoglobin (HbA1C)	Measured in fasting serum	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion rate from prediabetes to normal	Number of subjects in each arm that convert from prediabetic to normal glycemia	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total serum cholesterol concentration and lipoprotein-cholesterol concentrations	Serum lipid profile	12 weeks
Concentration of inflammatory markers	C-reactive protein, interleukin (IL)-1beta, IL-6, Tumour necrosis factor-alpha, Macrophage chemoattractant protein-1	12 weeks
Concentration of metabolic hormones	Insulin, Glucagon like peptide-1, Peptide YY, leptin, adiponectin, ghrelin,	12 weeks
Antioxidant capacity	Total antioxidant capacity of the lipid soluble fraction of plasma by chemiluminescent method (Photochem)	12 weeks
Microbiota composition	Quantitative analysis of main representative bacteria groups of gut microbiota by quantitative polymerase chain reaction	12 weeks

Collaborators and Investigators

• Sponsor: National Research Council, Spain
• Investigators: Principal Investigator: Esther NOVA, PhD, National Research Council of Spain

Publications and helpful links

General Publications

• Nova E, Redondo-Useros N, Martinez-Garcia RM, Gomez-Martinez S, Diaz-Prieto LE, Marcos A. Potential of Moringa oleifera to Improve Glucose Control for the Prevention of Diabetes and Related Metabolic Alterations: A Systematic Review of Animal and Human Studies. Nutrients. 2020 Jul 10;12(7):2050. doi: 10.3390/nu12072050.
• Vargas-Sanchez K, Garay-Jaramillo E, Gonzalez-Reyes RE. Effects of Moringa oleifera on Glycaemia and Insulin Levels: A Review of Animal and Human Studies. Nutrients. 2019 Dec 2;11(12):2907. doi: 10.3390/nu11122907.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2019
• Primary Completion (ACTUAL): May 5, 2020
• Study Completion (ACTUAL): January 26, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (ACTUAL): February 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: lipid metabolism; prevention; anti-inflammatory; Moringa oleifera; microbiota; functional food; anti-hyperglycemic effect
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: AGL2017-86044-C2-1-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Although a specific plan has not been conceived yet, sharing research data is a good practice that the investigators would pursue at due time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No