Clinical trial NCT04403217: Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes
Official title: Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Gut microbiota
Mediterranean diet
Type 2 diabetes
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in intestinal microbiota from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HbA1c levels (percent) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HOMA-IR from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HOMA-B (percent) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in HOMA-S (percent) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary outcomes:
measure: Changes in diet quality from baseline to visit 3
timeFrame: 1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in food intake from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in total body fat mass (kg) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in free fat mass (kg) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
measure: Changes in waist perimeter (cm) from baseline to visit 2 and 3
timeFrame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Study officials:
References: