Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-09-30

Brief Summary

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Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes. Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut barrier and that has positive impact in the metabolic control of subjects with type 2 diabetes. This is a 12-week, single-arm clinical study that aims to evaluate if the effect of Mediterranean diet in metabolic control of these subjects is mediated by gut microbiota. Subjects will receive personalized nutrition counseling where Mediterranean diet will be promoted.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized structured dietary plan based on MD

Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks

Group Type EXPERIMENTAL

Individualized structured dietary plan based on MD

Intervention Type OTHER

Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks

Interventions

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Individualized structured dietary plan based on MD

Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
* Ages 40-80 years;
* Non-smoker;
* Willing and able to provide written informed consent.

Exclusion Criteria

* Diabetes diagnosed before 40 years old;
* Changes in oral glycaemic-control medications in the last 3 months;
* Subjects with HbA1c levels under 6.4% or above 10%;
* Subjects under insulinotherapy;
* Subjects under corticotherapy;
* Subjects with triglycerides levels above 4.52 nmol/L (400 mg/dL);
* Intake of antibiotics in the last 12 weeks;
* Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No