Status:
UNKNOWN
Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease
Lead Sponsor:
University College Dublin
Collaborating Sponsors:
St. James's Hospital, Ireland
Conditions:
Non-Alcoholic Fatty Liver Disease
Liver Fat
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic ...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD), defined as the accumulation of fat in the liver that is not related to alcohol intake, is the number 1 global cause of chronic liver disease. Excessive consu...
Eligibility Criteria
Inclusion
- Males and females
- Age 18-65 years, from all ethnic groups, capable of providing informed consent to participate
- Obesity (body mass index \>30kg/m\^2) and of stable body weight (±3% for ≥3 months)
- Fasting blood glucose \<7.0 mmol/L and HbA1c \<6.5%.
- Liver fat \>10% (CAP score \>238 dB/m) and no fibrosis (liver stiffness score 2-7 kPa) as assessed by liver elastography (FibroScan)
Exclusion
- Impaired renal function
- Abnormal hematocrit
- History of cardiovascular events
- Uncontrolled hypertension
- Type 2 diabetes
- Medications or supplements known to affect glucose or lipid metabolism
- Active inflammatory, autoimmune, infectious, gastrointestinal, or malignant disease
- Uncontrolled neurological or psychiatric disease
- Iron deficiency anemia, (hemoglobin \< 12g/dl men, \< 11g/dl women)
- Fatty acid supplements and consumers of high doses of anti- antioxidant vitamins (A, C, E, b-carotene)
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05968378
Start Date
June 1 2023
End Date
July 1 2024
Last Update
August 1 2023
Active Locations (1)
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1
University College Dublin
Dublin, Leinster, Ireland, D04 V1W8