Supplementation of Eriocitrin in Intestinal Microbiota

NCT03925909 | Terminated

• 1 other identifier: SaoPSU 13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-diabetes is characterized by high plasma concentration of glucose and glycated hemoglobin and is the main risk factor for the development of type 2 diabetes. Several studies show that the intestinal microbiota is intimately linked to cardio-metabolic factors (type 2 diabetes, insulin resistance) when in situations of dysbiosis. Food is a key element for a healthy microbiota, focusing on the consumption of polyphenols that modulate the intestinal environment through its alteration and production of short chain fatty acids, and can thus be a way of reversing situations such as pre- diabetes and insulin resistance. The objective of the study will be to investigate whether chronic supplementation of eriocitrin alters the intestinal microbiota of pre-diabetic and insulin resistant individuals, reversing these situations. This will be done by supplementation of eriocitrin-containing capsules with different dosages in pre-diabetic and insulin resistant individuals. There will be 12 weeks of intervention, with faecal collections, anthropometric and dietary evaluation, and then will be made microbiological analysis to identify the intestinal microbiota and biochemical analysis before and after the intervention. For statistical analysis, normality and homogeneity test (Kolmogorov-Smirnov and Levine test respectively), T-test to compare baseline time between groups and repeated-measures ANOVA (two-way) were used to compare changes within and between groups.

Conditions

Pre Diabetes

Keywords

Eriocitrin; Citrus bioflavonoids; Flavanone; Pre-diabetes; Blood glucose; Microbiome

Outcome Measures

Primary Outcomes (1)

• Rate of change in microbiome

  Changes in microbiome before and after administration of the intervention / placebo

  0-12 week

Secondary Outcomes (1)

• Rate of change in plasma glucose concentration

  0-12 week

Study Arms (4)

Eriomin 200 mg

EXPERIMENTAL

The volunteers will receive one capsule containing 200 mg eriocitrin

Dietary Supplement: Eriocitrin

Eriomin 400 mg

EXPERIMENTAL

The volunteers will receive one capsule containing 400 mg eriocitrin

Dietary Supplement: Eriocitrin

Eriomin 800 mg

EXPERIMENTAL

The volunteers will receive one capsule containing 800 mg eriocitrin

Dietary Supplement: Eriocitrin

Placebo

NO INTERVENTION

The volunteers will receive a capsule containing corn starch (placebo)

Interventions

Eriocitrin DIETARY_SUPPLEMENT

The responsible nutritionists will do 1) Anthropometric Assessment, in which weight data will be collected (kg); height (m); waist circumference (cm), waist circumference (cm) and hip circumference (cm), muscle mass (kg /%) and percentage of fat by means of bioimpedance equipment; 2) Dietary assessment, which will be performed through a 24-hour Food Recall, a 3-day Food Record and a Food Consumption Frequency Questionnaire; 3) Evaluation of the microbiota, for which stool will be collected from the last 24 hours on the day before the beginning of the experiment and at the end of the study (week 12); 3) Biochemical evaluation, which includes the collection of 30 mL of blood to be performed by trained and qualified technicians.

Eriomin 200 mg; Eriomin 400 mg; Eriomin 800 mg

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Increased fasting blood glucose from 6.1 to 7.0 mmol / L or,
• Decreased glucose tolerance of 7 , 8 to 11.1 mmol / L or,
• Glycated hemoglobin with values between 5.7 and 6.4%

You may not qualify if:

• Use hypoglycemic, hypolipidemic drugs,
• Use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds),
• Exercise intensely (more than 10 hours per week)
• History of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

Sponsors & Collaborators

• São Paulo State University: lead

Study Sites (1)

Sao Paulo State University "Julio de Mesquita Filho"

Araraquara, São Paulo, 14800-903, Brazil

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

eriocitrin

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thais B Cesar, Phd

  ao Paulo State University "Julio de Mesquita Filho"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 24, 2019
• Study Start: May 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: March 23, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)