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

NCT04734132 | Completed

• 1 other identifier: AGL2017-86044-C2-1-R
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

Moringa oleifera; functional food; anti-hyperglycemic effect; prevention; anti-inflammatory; microbiota; lipid metabolism

Outcome Measures

Primary Outcomes (2)

• Fasting Blood Glucose

  Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube

  12 weeks

• Glycated hemoglobin (HbA1C)

  Measured in fasting serum

  12 weeks

Secondary Outcomes (1)

• Conversion rate from prediabetes to normal

  12 weeks

Other Outcomes (5)

• Total serum cholesterol concentration and lipoprotein-cholesterol concentrations

  12 weeks

• Concentration of inflammatory markers

  12 weeks

• Concentration of metabolic hormones

  12 weeks

Study Arms (2)

Moringa

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Six placebo capsules containing microcrystalline cellulose consumed daily during 12 weeks. Two capsules consumed with each of the three main meals.

Dietary Supplement: Placebo

Interventions

Moringa DIETARY_SUPPLEMENT

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.

Moringa

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead

Study Sites (1)

Institute of Food Science and Technology and Nutrition (ICTAN)-CSIC

Madrid, 28040, Spain

Location

Related Publications (2)

• 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.

  PMID: 32664295 BACKGROUND

• 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.

  PMID: 31810205 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Interventions

flocculant protein MO 2.1, Moringa oleifera

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Esther NOVA, PhD

  National Research Council of Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One member of the research team was in charge of product preparation and delivery to the participants following the randomization list.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind, randomized, parallel group, placebo-controlled dietary intervention in prediabetic subjects.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: January 22, 2019
• Primary Completion: May 5, 2020
• Study Completion: January 26, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

ES (1)