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

Type 2 Diabetes Clinical Trial

— MEDBIOME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04403217
• Other study ID #: MEDBIOME
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2020
• Source: Universidade Nova de Lisboa
• Contact: Conceição Calhau
• Phone: +351218803000
• Email: ccalhau[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Individualized structured dietary plan based on MD
Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks

Locations

Country	Name	City	State
Portugal	NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes 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	1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)
Primary	Changes in HbA1c levels (percent) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Primary	Changes in HOMA-IR from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Primary	Changes in HOMA-B (percent) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Primary	Changes in HOMA-S (percent) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Primary	Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Primary	Changes in fasting insulin (µU/mL) levels from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	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.	1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)
Secondary	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	1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in total body fat mass (kg) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in free fat mass (kg) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)
Secondary	Changes in waist perimeter (cm) from baseline to visit 2 and 3		1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)