Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile in Prediabetic Patients

PreDiabetes Clinical Trial

— NUTRIMOL-DB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734132
• Other study ID #: AGL2017-86044-C2-1-R
• Status: Completed
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: January 26, 2021

Study information

• Verified date: February 2021
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 26, 2021
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Moringa
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
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.

Locations

Country	Name	City	State
Spain	Institute of Food Science and Technology and Nutrition (ICTAN)-CSIC	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
National Research Council, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Nova E, Redondo-Useros N, Martínez-García RM, Gómez-Martínez S, Díaz-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). pii: E2050. doi: 10.3390/nu12072050. Review. — View Citation

Vargas-Sánchez K, Garay-Jaramillo E, González-Reyes RE. Effects of Moringa oleifera on Glycaemia and Insulin Levels: A Review of Animal and Human Studies. Nutrients. 2019 Dec 2;11(12). pii: E2907. doi: 10.3390/nu11122907. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total serum cholesterol concentration and lipoprotein-cholesterol concentrations	Serum lipid profile	12 weeks
Other	Concentration of inflammatory markers	C-reactive protein, interleukin (IL)-1beta, IL-6, Tumour necrosis factor-alpha, Macrophage chemoattractant protein-1	12 weeks
Other	Concentration of metabolic hormones	Insulin, Glucagon like peptide-1, Peptide YY, leptin, adiponectin, ghrelin,	12 weeks
Other	Antioxidant capacity	Total antioxidant capacity of the lipid soluble fraction of plasma by chemiluminescent method (Photochem)	12 weeks
Other	Microbiota composition	Quantitative analysis of main representative bacteria groups of gut microbiota by quantitative polymerase chain reaction	12 weeks
Primary	Fasting Blood Glucose	Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube	12 weeks
Primary	Glycated hemoglobin (HbA1C)	Measured in fasting serum	12 weeks
Secondary	Conversion rate from prediabetes to normal	Number of subjects in each arm that convert from prediabetic to normal glycemia	12 weeks