Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250309
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-01
Brief Title:
Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center proof-of-concept pilot study which uses a cross-over design to compare two dietary interventionstreatments Western Diet WD vs Mediterranean MD and impact on quality-of-life parameters in AIH Participants will receive both treatments through two phases and will be divided into two groups
Detailed Description:
Autoimmune hepatitis AIH patients have dramatically reduced quality of life compared to healthy controls Many symptoms that drive this reduction remain well known yet clinicians have little to no data on interventions that may reduce symptom burden
As awareness of the broad life impact of autoimmune hepatitis AIH has increased a more comprehensive clinical model that considers other medical interventions such as diet has become more important to patients Diet has been an area of important study in a number of other auto-inflammatory diseases particularly focused on pathogenesis symptomatic treatment and even modification of clinical outcomes in a number of autoimmune illnesses
As complex diseases autoimmune illnesses such as rheumatoid arthritis multiple sclerosis and even lupus are the result of both genetic and environmental risk factors Environmental contributions from diet are ubiquitous and the increased prevalence of autoimmune illnesses in North America has been hypothesized in part related to western diet WD Characterized by a high intake of red meat saturated and trans fats a low ratio of omega-3omega-6 fatty acids and high consumption of refined carbohydrates WD has been associated with an increased risk of autoimmunity principally through an increase of inflammation and an induction of insulin-resistance and obesity
To date the Mediterranean diet MD has the most evidence as a disease modifying intervention in autoimmune illnesses MDs protective properties are related to antioxidant and anti-inflammatory effect may related to abundance of several nutrients especially dietary fiber magnesium omega 3 and mono-unsaturated fatty acids polyphenols and tocopherols that promote a reduction in inflammation as well as insulin-resistance and thereby protect from diabetes and cardiovascular disease Unfortunately in rheumatoid arthritis RA the anti-inflammatory properties of MD impact on disease development and progression have been mixed Yet MD consumption has been shown to provide a symptomatic improvement including disease activity inflammatory markers and physical function
Fatigue is the most prevalent symptom among AIH patients and has the most dramatic impact on quality of life Current guidelines have no specific guidance to treatment or management of fatigue beyond seeking other medical contributions ie anemia cardiac disease hypothyroidism Dietary changes have not been investigated as a therapeutic approach in AIH despite data from other autoimmune diseases
A total of 48 subjects will be randomized by a computer program into one of two groups MD or WD This is a cross-over study and after completion of the initial randomized arm MD or WD the study patient will enter the opposite dietary intervention as the first arm The study team PI and study coordinator will remain blind to the diet intervention study Randomization arm information will be provided to the nutritional team preparing diets for treatment arms The patients will also remain blinded to the diet type in each arm despite patient understanding of dietary components may reveal the investigational diet arm they are currently receiving
As awareness of the broad life impact of autoimmune hepatitis AIH has increased a more comprehensive clinical model that considers other medical interventions such as diet has become more important to patients Diet has been an area of important study in a number of other auto-inflammatory diseases particularly focused on pathogenesis symptomatic treatment and even modification of clinical outcomes in a number of autoimmune illnesses
As complex diseases autoimmune illnesses such as rheumatoid arthritis multiple sclerosis and even lupus are the result of both genetic and environmental risk factors Environmental contributions from diet are ubiquitous and the increased prevalence of autoimmune illnesses in North America has been hypothesized in part related to western diet WD Characterized by a high intake of red meat saturated and trans fats a low ratio of omega-3omega-6 fatty acids and high consumption of refined carbohydrates WD has been associated with an increased risk of autoimmunity principally through an increase of inflammation and an induction of insulin-resistance and obesity
To date the Mediterranean diet MD has the most evidence as a disease modifying intervention in autoimmune illnesses MDs protective properties are related to antioxidant and anti-inflammatory effect may related to abundance of several nutrients especially dietary fiber magnesium omega 3 and mono-unsaturated fatty acids polyphenols and tocopherols that promote a reduction in inflammation as well as insulin-resistance and thereby protect from diabetes and cardiovascular disease Unfortunately in rheumatoid arthritis RA the anti-inflammatory properties of MD impact on disease development and progression have been mixed Yet MD consumption has been shown to provide a symptomatic improvement including disease activity inflammatory markers and physical function
Fatigue is the most prevalent symptom among AIH patients and has the most dramatic impact on quality of life Current guidelines have no specific guidance to treatment or management of fatigue beyond seeking other medical contributions ie anemia cardiac disease hypothyroidism Dietary changes have not been investigated as a therapeutic approach in AIH despite data from other autoimmune diseases
A total of 48 subjects will be randomized by a computer program into one of two groups MD or WD This is a cross-over study and after completion of the initial randomized arm MD or WD the study patient will enter the opposite dietary intervention as the first arm The study team PI and study coordinator will remain blind to the diet intervention study Randomization arm information will be provided to the nutritional team preparing diets for treatment arms The patients will also remain blinded to the diet type in each arm despite patient understanding of dietary components may reveal the investigational diet arm they are currently receiving
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None