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

Sponsor

National Research Council, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT04734132

Collaborator

(none)

Enrollment

Location

Arms

24.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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

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.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 :

Jan 22, 2019

Actual Primary Completion Date :

May 5, 2020

Actual Study Completion Date :

Jan 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.

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

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Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube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

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.