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Completed

NCT Number: NCT04734132

Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile 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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moringa

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Registry information

Official study title

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

Acronym: NUTRIMOL-DB

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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