Clinical trial NCT04734132: Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile in Prediabetic Patients
Official title: Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile. Nutritional Intervention Study in Prediabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Moringa oleifera
functional food
anti-hyperglycemic effect
prevention
anti-inflammatory
microbiota
lipid metabolism
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
First posted: 2021-02-02
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized, parallel group, placebo-controlled dietary intervention in prediabetic subjects.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: 12 weeks
measure: Glycated hemoglobin (HbA1C)
timeFrame: 12 weeks
Secondary outcomes:
measure: Conversion rate from prediabetes to normal
timeFrame: 12 weeks
Other outcomes:
measure: Total serum cholesterol concentration and lipoprotein-cholesterol concentrations
timeFrame: 12 weeks
measure: Concentration of inflammatory markers
timeFrame: 12 weeks
measure: Concentration of metabolic hormones
timeFrame: 12 weeks
measure: Antioxidant capacity
timeFrame: 12 weeks
measure: Microbiota composition
timeFrame: 12 weeks
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science and Technology and Nutrition (ICTAN)-CSIC
Study officials:
affiliation: National Research Council of Spain
name: Esther NOVA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nova E, Redondo-Useros N, Martinez-Garcia RM, Gomez-Martinez S, Diaz-Prieto LE, Marcos A. Potential of Moringa oleifera to Improve Glucose Control for the Prevention of Diabetes and Related Metabolic Alterations: A Systematic Review of Animal and Human Studies. Nutrients. 2020 Jul 10;12(7):2050. doi: 10.3390/nu12072050.
citation: Vargas-Sanchez K, Garay-Jaramillo E, Gonzalez-Reyes RE. Effects of Moringa oleifera on Glycaemia and Insulin Levels: A Review of Animal and Human Studies. Nutrients. 2019 Dec 2;11(12):2907. doi: 10.3390/nu11122907.