An interventional study of Moringa and Placebo in PreDiabetes, sponsored by National Research Council, Spain. Completed at 1 site in Spain. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by National Research Council, Spain · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 72 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
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Exclusion Criteria:
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
Six placebo capsules containing microcrystalline cellulose consumed daily during 12 weeks. Two capsules consumed with each of the three main meals.
Dietary Supplement: Placebo
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.
Fasting Blood Glucose
Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube
Time frame: 12 weeks
Glycated hemoglobin (HbA1C)
Measured in fasting serum
Time frame: 12 weeks
Conversion rate from prediabetes to normal
Number of subjects in each arm that convert from prediabetic to normal glycemia
Time frame: 12 weeks
Total serum cholesterol concentration and lipoprotein-cholesterol concentrations
Serum lipid profile
Time frame: 12 weeks
Concentration of inflammatory markers
C-reactive protein, interleukin (IL)-1beta, IL-6, Tumour necrosis factor-alpha, Macrophage chemoattractant protein-1
Time frame: 12 weeks
Concentration of metabolic hormones
Insulin, Glucagon like peptide-1, Peptide YY, leptin, adiponectin, ghrelin,
Time frame: 12 weeks
Antioxidant capacity
Total antioxidant capacity of the lipid soluble fraction of plasma by chemiluminescent method (Photochem)
Time frame: 12 weeks
Microbiota composition
Quantitative analysis of main representative bacteria groups of gut microbiota by quantitative polymerase chain reaction
Time frame: 12 weeks
Plan to share: Undecided — Although a specific plan has not been conceived yet, sharing research data is a good practice that the investigators would pursue at due time.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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National Research Council, Spain