Clinical trial NCT03925909: Supplementation of Eriocitrin in Intestinal Microbiota
Official title: Effect of Chronic Eriocitrin Supplementation on the Intestinal Microbiota of Pre-diabetic and Insulin Resistant Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre Diabetes
Keywords: Eriocitrin
Citrus bioflavonoids
Flavanone
Pre-diabetes
Blood glucose
Microbiome
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Individuals of both sexes between 30 and 60 years of age who present fasting glycemia between 100 mg / dL (5,6 mmol / L) and 125 mg / dL (6,9 mmol / L) 50, or concentration of glycated hemoglobin between 5.7% (39 mmol / mole) and 6.4% (47 mmol / mole) 50, or glycemic concentrations in the oral glucose tolerance test between 140mg / dL (7.8 mmol / L) to 199mg / dL (11.0 mmol / L) 50. The study will also include insulin-resistant individuals: insulin above 25 uU / mL, or who present HOMA-IR score above 2.7.

Individuals using supplements (vitamins, bioflavonoids), pregnant women and those who practice intense physical exercise (\> 10h / week) will be excluded from the study.

The primary endpoint will be alteration of the microbiota with possible improvement of the glycemic profile, leading to the reversal of pre-diabetes and insulin resistance.

Eligibility criteria: Inclusion Criteria:

* 30-60 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%

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of change in microbiome
timeFrame: 0-12 week
Secondary outcomes:
measure: Rate of change in plasma glucose concentration
timeFrame: 0-12 week
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Sao Paulo State University "Julio de Mesquita Filho"
state: SP
Study officials:
affiliation: ao Paulo State University "Julio de Mesquita Filho"
name: Thais B Cesar, Phd
role: PRINCIPAL_INVESTIGATOR
References: