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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon, Portugal
RECRUITINGChanges in intestinal microbiota from baseline to visit 2 and 3
Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)
Changes in HbA1c levels (percent) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in HOMA-IR from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in HOMA-B (percent) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in HOMA-S (percent) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
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Changes in diet quality from baseline to visit 3
Mediterranean diet adherence will be evaluated using the Mediterranean Diet Adherence Screener (MEDAS) from the PREvención com Dieta MEDiterránea (PREDIMED) study. Responses that are favorable to the adoption of the Mediterranean diet are scored as 1 point, while responses that are unfavorable are scored as 0. The final score ranged between 0 and 14 and a MEDAS score greater than 9 indicates high adherence to the Mediterranean diet.
Time frame: 1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)
Changes in food intake from baseline to visit 2 and 3
3 non-consecutive 24-h dietary food recall using a photographic manual for food quantification
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in total body fat mass (kg) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in free fat mass (kg) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Changes in waist perimeter (cm) from baseline to visit 2 and 3
Time frame: 1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)