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

PreDiabetes Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

• NCT number: NCT04734132
• Study type: Interventional
• Source: National Research Council, Spain
• Status: Completed
• Phase: N/A
• Start date: January 22, 2019
• Completion date: January 26, 2021