PreDiabetes
Conditions
Keywords
Moringa oleifera, functional food, anti-hyperglycemic effect, prevention, anti-inflammatory, microbiota, lipid metabolism
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.
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.
Interventions
DIETARY_SUPPLEMENTMoringa
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Double blind, randomized, parallel group, placebo-controlled dietary intervention in prediabetic subjects.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate from prediabetes to normal | 12 weeks | Number of subjects in each arm that convert from prediabetic to normal glycemia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Antioxidant capacity | 12 weeks | Total antioxidant capacity of the lipid soluble fraction of plasma by chemiluminescent method (Photochem) |
| Total serum cholesterol concentration and lipoprotein-cholesterol concentrations | 12 weeks | Serum lipid profile |
| Microbiota composition | 12 weeks | Quantitative analysis of main representative bacteria groups of gut microbiota by quantitative polymerase chain reaction |
| 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, |
Countries
Spain
Outcome results
None listed