Response of NAFLD Patients to Mediterranean Diet

NCT03203486 | Completed

• 1 other identifier: 09-ΣΥΝ-12-890
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NAFLD; Steatosis of Liver

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Regulation of hepatic steatosis

  A decrease in liver fat

  Change from Baseline to 6 months

Secondary Outcomes (4)

• Adherence to MedDiet

  Change from Baseline to 6 months

• Regulation of visfatin

  Change from Baseline to 6 months

• Regulation of oxLDL

  Change from Baseline to 6 months

• Association of single nucleotide polymorphisms to response to dietary treatment

  Change from Baseline to 6 months

Study Arms (1)

Meditteranean Diet

EXPERIMENTAL

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

Other: Mediterranean Diet

Interventions

Mediterranean Diet OTHER

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.

Meditteranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator
• Greek Secretariat for Research and Technology: collaborator

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Andriana C Kaliora, PhD

  Harokopio University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Human Nutrition and Foods

Model Details: non-randomised, open-label study

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 29, 2017
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share