Personalised dietary advice and liver improvement- version 1
Research type
Research Study
Full title
Assessing metabolic profiling strategies for nutritional management in diabetic patients with Non-Alcoholic Fatty Liver Disease
IRAS ID
288979
Contact name
Isabel Garcia-perez
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
TITLE Assessing metabolic profiling strategies for nutritional management in diabetic patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
BACKGROUND:
The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing with an estimated at 20–30% of UK population, placing a greater burden on healthcare resources. NAFLD is a frequent finding in patients with type 2 diabetes mellitus. Adopting a healthy lifestyle with diet being a major contributing factor is the main way of managing NAFLD and diabetes. However, although the adoption of healthy dietary patterns has unequivocally been shown to prevent the conditions getting worse, the adoption of these guidelines has not been extensive enough to impact sufficiently on NAFLD and diabetes statistics and the numbers are still increasing year-on-year in the UK with an increasing health burden worldwide. Therefore, there are concerns regarding the ineffectiveness of ‘one-size-fits-all’ dietary advice, considering the possibilities whether due to the diet’s biological ineffectiveness or poor adherence to dietary recommendations, or high inter-individual variability in responses to a recommended diet. Recent data shows that personalised nutritional advice has a more significant impact on dietary change than general nutritional advice.
STUDY DESIGN
An open-label randomized control trial for diabetic patients with NAFLD comparing dietary advice and feedback informed by metabolic profiling to standard of care aiming to improve dietary habits during a 12-week period. The control group (n=67) will receive standard advice using NHS guidelines based on dietary intake recorded by food diaries. The target group (n=67) will mirror the control group but will receive an enhanced personalised dietary advice based on their accurate dietary intake assessment and their metabolic response to the diet measured by urinary metabolic fingerprint.
ELIGIBILITY
Diabetic patients with Non-Alcoholic Fatty Liver Disease (NAFLD), aged above 18 years regardless of gender or ethnicity.
STUDY SITE:
Outpatient clinics, Imperial College Healthcare NHS TrustREC name
North West - Preston Research Ethics Committee
REC reference
21/NW/0272
Date of REC Opinion
7 Apr 2022
REC opinion
Further Information Favourable Opinion