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

• ClinicalTrials.gov Identifier: NCT04734132
• Recruitment Status: Completed
• First Posted: February 2, 2021
• Last Update Posted: February 5, 2021
• Sponsor: National Research Council, Spain
• Information provided by (Responsible Party): Esther Nova Rebato, National Research Council, Spain

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
PreDiabetes	Dietary Supplement: Moringa; Dietary Supplement: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind, randomized, parallel group, placebo-controlled dietary intervention in prediabetic subjects.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: One member of the research team was in charge of product preparation and delivery to the participants following the randomization list.
• Primary Purpose: Prevention
• Official Title: Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile. Nutritional Intervention Study in Prediabetic Patients
• Actual Study Start Date: January 22, 2019
• Actual Primary Completion Date: May 5, 2020
• Actual Study Completion Date: January 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Fasting Blood Glucose [ Time Frame: 12 weeks ]
   Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube
2. Glycated hemoglobin (HbA1C) [ Time Frame: 12 weeks ]
   Measured in fasting serum

Secondary Outcome Measures :

1. Conversion rate from prediabetes to normal [ Time Frame: 12 weeks ]
   Number of subjects in each arm that convert from prediabetic to normal glycemia

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Spain

Institute of Food Science and Technology and Nutrition (ICTAN)-CSIC

Madrid, Spain, 28040

Sponsors and Collaborators

National Research Council, Spain

Investigators

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

More Information

Publications:

Nova E, Redondo-Useros N, Martínez-García RM, Gómez-Martínez S, Díaz-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). pii: E2050. doi: 10.3390/nu12072050.

Vargas-Sánchez K, Garay-Jaramillo E, González-Reyes RE. Effects of Moringa oleifera on Glycaemia and Insulin Levels: A Review of Animal and Human Studies. Nutrients. 2019 Dec 2;11(12). pii: E2907. doi: 10.3390/nu11122907. Review.

• Responsible Party: Esther Nova Rebato, Principal Investigator, National Research Council, Spain
• ClinicalTrials.gov Identifier: NCT04734132
• Other Study ID Numbers: AGL2017-86044-C2-1-R
• First Posted: February 2, 2021
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Esther Nova Rebato, National Research Council, Spain:

Moringa oleifera; functional food; anti-hyperglycemic effect; prevention; anti-inflammatory; microbiota; lipid metabolism

Additional relevant MeSH terms:

Prediabetic State; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases