Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile in Prediabetic Patients
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

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.
    

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.
    

Intervention name(s): Moringa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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 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.
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)
Primary purpose: Prevention
Keywords: Moringa oleifera; functional food; anti-hyperglycemic effect; prevention; anti-inflammatory; microbiota; lipid metabolism