Back to results

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

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Individualized structured dietary plan based on MD

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Gut microbiota, Mediterranean diet, Type 2 diabetes

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de LisboaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individualized structured dietary plan based on MD

Arm Description

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

Outcomes

Primary Outcome Measures

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

Changes in HbA1c levels (percent) from baseline to visit 2 and 3

Changes in HOMA-IR from baseline to visit 2 and 3

Changes in HOMA-B (percent) from baseline to visit 2 and 3

Changes in HOMA-S (percent) from baseline to visit 2 and 3

Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3

Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3

Secondary Outcome Measures

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.

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

Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3

Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3

Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3

Changes in fasting serum triglycerides (mg/dL) from baseline to visit 2 and 3

Changes in total body fat mass (kg) from baseline to visit 2 and 3

Changes in free fat mass (kg) from baseline to visit 2 and 3

Changes in waist perimeter (cm) from baseline to visit 2 and 3

Full Information

NCT ID

NCT04403217

First Posted

May 20, 2020

Last Updated

May 25, 2020

Sponsor

Universidade Nova de Lisboa

1. Study Identification

Unique Protocol Identification Number

NCT04403217

Brief Title

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

Acronym

MEDBIOME

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

July 31, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidade Nova de Lisboa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Gut microbiota, Mediterranean diet, Type 2 diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Individualized structured dietary plan based on MD

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Individualized structured dietary plan based on MD

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in intestinal microbiota from baseline to visit 2 and 3

Description

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Secondary Outcome Measure Information:

Title

Changes in diet quality from baseline to visit 3

Description

Time Frame

1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)

Title

Changes in food intake from baseline to visit 2 and 3

Description

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Conceição Calhau

Phone

+351218803000

ccalhau@nms.unl.pt

Facility Information:

Facility Name

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

City

Lisbon

ZIP/Postal Code

1169-056

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Conceição Calhau

Phone

+351918482491

diabeer@nms.unl.pt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs