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Response of NAFLD Patients to Mediterranean Diet

Primary Purpose

NAFLD, Steatosis of Liver

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mediterranean Diet

About this trial

This is an interventional other trial for NAFLD focused on measuring NAFLD, no fibrosis, Mediterranean diet, STAT3, GCKR, visfatin, oxidized LDL, fasting glucose, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

men and women >18y of age, no change in body weight (BW) for the last 6 months prior to the trial and body mass index (BMI) >25 kg/m2.

Exclusion Criteria:

the presence of chronic viral hepatitis, the presence of congenital or acquired liver disease, the history of prior exposure to hepatotoxic drugs, the evidence of hepatic cirrhosis, ultrasonography values less than 1Hz, bariatric surgery, daily consumption of ethanol more than 20g for women and more than 30g for men for over 6 months during the last 5 years, any medication effective on fatty liver disease introduced <6 months prior to or during the trial, the co-presence of a life-threatening disease, psychiatric disorders impairing the patient's ability to provide written informed consent, age>65 years, pregnant or lactating women, subjects supplemented with omega-3 polyunsaturated fatty acids, probiotics/synbiotics, antioxidant vitamins and/or phytochemicals, any planned, structured and repetitive physical activity. Patients with any medication change during the trial were excluded from analysis.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meditteranean Diet

Arm Description

NAFLD patients attended appointments with experienced dieticians to receive nutritional guidance based on a traditional Mediterranean Diet for 6 months.

Outcomes

Primary Outcome Measures

Regulation of hepatic steatosis

A decrease in liver fat

Secondary Outcome Measures

Adherence to MedDiet

Increase in MedDietScore

Regulation of visfatin

Decrease in visfatin levels

Regulation of oxLDL

Decrease in oxLDL levels

Association of single nucleotide polymorphisms to response to dietary treatment

Decrease in visfatin in carriers of the risk allele

Full Information

NCT ID

NCT03203486

First Posted

June 26, 2017

Last Updated

June 27, 2017

Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens, Greek Secretariat for Research and Technology

1. Study Identification

Unique Protocol Identification Number

NCT03203486

Brief Title

Response of NAFLD Patients to Mediterranean Diet

Official Title

The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens, Greek Secretariat for Research and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile were also investigated.

Detailed Description

Diet is a modifiable key factor targeted in prevention and management of non-alcoholic fatty liver disease (NAFLD). The aim of the study is to investigate the effect of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile are investigated. In this non-randomised, open-label study, 44 untreated NAFLD patients with non significant fibrosis receive nutritional counsel to increase adherence to MedDiet. Adherence to MedDiet is estimated with MedDietScore. Furthermore, genotyping of STAT3 rs2293152 and GCKR rs1260326 single nucleotide polymorphisms takes place.

6. Conditions and Keywords

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

NAFLD, Steatosis of Liver

Keywords

NAFLD, no fibrosis, Mediterranean diet, STAT3, GCKR, visfatin, oxidized LDL, fasting glucose, inflammation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

non-randomised, open-label study

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meditteranean Diet

Arm Type

Experimental

Arm Description

NAFLD patients attended appointments with experienced dieticians to receive nutritional guidance based on a traditional Mediterranean Diet for 6 months.

Intervention Type

Other

Intervention Name(s)

Mediterranean Diet

Intervention Description

Participants were instructed to include vegetables, whole grains and fruits in their diet and increase fish, legumes and raw nut intake. Emphasis was given to extra virgin olive oil as the main added fat in meals. Particular attention was drained to decrease fermented dairy and poultry, with small amounts of red meat and homemade sweets. All participants were given meal plans in which the distribution of nutrients in relation to total caloric value was as follows: 40% of total energy as fat (50% as MUFAs), 20% as protein, 40% as carbohydrate, 300mg/d as dietary cholesterol and 20-30g fiber/d.

Primary Outcome Measure Information:

Title

Regulation of hepatic steatosis

Description

A decrease in liver fat

Time Frame

Change from Baseline to 6 months

Secondary Outcome Measure Information:

Title

Adherence to MedDiet

Description

Increase in MedDietScore

Time Frame

Change from Baseline to 6 months

Title

Regulation of visfatin

Description

Decrease in visfatin levels

Time Frame

Change from Baseline to 6 months

Title

Regulation of oxLDL

Description

Decrease in oxLDL levels

Time Frame

Change from Baseline to 6 months

Title

Association of single nucleotide polymorphisms to response to dietary treatment

Description

Decrease in visfatin in carriers of the risk allele

Time Frame

Change from Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: men and women >18y of age, no change in body weight (BW) for the last 6 months prior to the trial and body mass index (BMI) >25 kg/m2. Exclusion Criteria: the presence of chronic viral hepatitis, the presence of congenital or acquired liver disease, the history of prior exposure to hepatotoxic drugs, the evidence of hepatic cirrhosis, ultrasonography values less than 1Hz, bariatric surgery, daily consumption of ethanol more than 20g for women and more than 30g for men for over 6 months during the last 5 years, any medication effective on fatty liver disease introduced <6 months prior to or during the trial, the co-presence of a life-threatening disease, psychiatric disorders impairing the patient's ability to provide written informed consent, age>65 years, pregnant or lactating women, subjects supplemented with omega-3 polyunsaturated fatty acids, probiotics/synbiotics, antioxidant vitamins and/or phytochemicals, any planned, structured and repetitive physical activity. Patients with any medication change during the trial were excluded from analysis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andriana C Kaliora, PhD

Organizational Affiliation

Harokopio University of Athens

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Response of NAFLD Patients to Mediterranean Diet

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