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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Universidade Nova de Lisboa
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Updated on 16 February 2024
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microbiota

Summary

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.

Details
Condition NIDDM, diabetes mellitus, type 2, Diabetes Mellitus, diabetes (pediatric), diabetes (pediatric), diabetes mellitus, type 2
Age 40years - 80years
Treatment Individualized structured dietary plan based on MD
Clinical Study IdentifierNCT04403217
SponsorUniversidade Nova de Lisboa
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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