Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease

NCT05968378 | Unknown DMC

• 1 other identifier: LS-E-22-105-Shannon-Roche
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 fatty liver disease (NAFLD).

Conditions

Non-Alcoholic Fatty Liver Disease; Liver Fat; Obesity; Inflammation

Outcome Measures

Primary Outcomes (4)

• Change in plasma inflammatory response to a high-fat meal: C-reactive protein (CRP)

  Postprandial changes in CRP (mg/L) will be measured in response to a high-fat meal

  To be assessed at baseline and post 8-week intervention

• Change in plasma inflammatory response to a high-fat meal: Interleukin-6 (IL-6)

  Postprandial changes in IL-6 (pg/mL) will be measured in response to a high-fat meal

  To be assessed at baseline and post 8-week intervention

• Change in plasma inflammatory response to a high-fat meal: Interleukin-1-beta (IL-1β)

  Postprandial changes in IL-1β (pg/mL) will be measured in response to a high-fat meal

  To be assessed at baseline and post 8-week intervention

• Change in plasma inflammatory response to a high-fat meal: Tumor necrosis factor alpha (TNF-α)

  Postprandial changes in (TNF-α) (pg/mL) will be measured in response to a high-fat meal

  To be assessed at baseline and post 8-week intervention

Secondary Outcomes (20)

• Change in metabolic response to a high-fat meal: Glucose

  To be assessed at baseline and post 8-week intervention

• Change in metabolic response to a high-fat meal: Insulin

  To be assessed at baseline and post 8-week intervention

• Change in metabolic response to a high-fat meal: Glucagon

  To be assessed at baseline and post 8-week intervention

• Change in metabolic response to a high-fat meal: Triglycerides

  To be assessed at baseline and post 8-week intervention

• Change in metabolic response to a high-fat meal: Non-esterified fatty acids (NEFA)

  To be assessed at baseline and post 8-week intervention

Study Arms (2)

Standard healthy eating advice

ACTIVE COMPARATOR

Subjects in this group will be counselled according to the Irish National Healthy Eating Guidelines.

Behavioral: Standard healthy eating advice

eTRE plus Mediterranean diet

EXPERIMENTAL

Subjects in this group will be asked to restrict their eating to 8-hours daily (8am - 4pm) and to adhere to a Mediterranean style diet.

Behavioral: eTRE plus Mediterranean diet

Interventions

Standard healthy eating advice BEHAVIORAL

Subjects in this group will be provided with standard healthy eating advice according to the Irish National Healthy Eating Guidelines and Food Pyramid and will be asked to follow this advice for 8-weeks.

Standard healthy eating advice

eTRE plus Mediterranean diet BEHAVIORAL

Subjects in this group will be asked to consume all meals between 8am - 4pm and to adhere to a Mediterranean style diet daily for 8-weeks.

eTRE plus Mediterranean diet

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Dublin: lead
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

University College Dublin

Dublin, Leinster, D04 V1W8, Ireland

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Obesity; Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Helen M Roche, Professor

CONTACT

+353017164031; helen.roche@ucd.ie

Christopher E Shannon, PhD

CONTACT

christopher.shannon@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 1, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

IE (1)