Response of NAFLD Patients to Mediterranean Diet

• ClinicalTrials.gov Identifier: NCT03203486
• Recruitment Status: Completed
• First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens; Greek Secretariat for Research and Technology
• Information provided by (Responsible Party): Andriana C Kaliora, Harokopio University

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.

Condition or disease	Intervention/treatment	Phase
NAFLD; Steatosis of Liver	Other: Mediterranean Diet	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: non-randomised, open-label study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course
• Actual Study Start Date: April 2014
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm

Intervention/treatment

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

Other: Mediterranean Diet; 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.

Outcome Measures

Primary Outcome Measures :

1. Regulation of hepatic steatosis [ Time Frame: Change from Baseline to 6 months ]
   A decrease in liver fat

Secondary Outcome Measures :

1. Adherence to MedDiet [ Time Frame: Change from Baseline to 6 months ]
   Increase in MedDietScore
2. Regulation of visfatin [ Time Frame: Change from Baseline to 6 months ]
   Decrease in visfatin levels
3. Regulation of oxLDL [ Time Frame: Change from Baseline to 6 months ]
   Decrease in oxLDL levels
4. Association of single nucleotide polymorphisms to response to dietary treatment [ Time Frame: Change from Baseline to 6 months ]
   Decrease in visfatin in carriers of the risk allele

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Harokopio University

National and Kapodistrian University of Athens

Greek Secretariat for Research and Technology

Investigators

• Principal Investigator: Andriana C Kaliora, PhD; Harokopio University of Athens

More Information

• Responsible Party: Andriana C Kaliora, Assistant Professor, Human Nutrition and Foods, Harokopio University
• ClinicalTrials.gov Identifier: NCT03203486
• Other Study ID Numbers: 09-ΣΥΝ-12-890
• First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andriana C Kaliora, Harokopio University:

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

Additional relevant MeSH terms:

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Digestive System Diseases