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Behavioural Intervention
Ketogenic Diet for NASH Cirrhosis Weight Loss
N/A
Recruiting
Led By Raj Vuppalanchi, M.D.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NASH cirrhosis with obesity (BMI >30 kg/m2)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the poms 40 questionnaire is administered at the week 16 visit.
Awards & highlights
Study Summary
This trial will compare a ketogenic diet to a standard diet, and will measure weight loss over 16 weeks.
Who is the study for?
This trial is for obese individuals with a BMI over 30 who have NASH cirrhosis but no other major health issues like uncontrolled diabetes, significant alcohol consumption, or heart failure. It's not for those on weight loss drugs, in another fatty liver disease study, or with devices like pacemakers.Check my eligibility
What is being tested?
The study compares the effects of a ketogenic diet (SKD) to standard dietary care (SOC) over 16 weeks in promoting weight loss among participants. Those in the SOC group will get a Weight Watchers voucher after completing the study.See study design
What are the potential side effects?
Potential side effects from following a ketogenic diet may include fatigue, headache, dizziness during initial adaptation ('keto flu'), nutrient deficiencies if not properly managed and potential exacerbation of existing liver conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have NASH cirrhosis and my BMI is over 30.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the poms 40 questionnaire is administered at the week 16 visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the poms 40 questionnaire is administered at the week 16 visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Blood chemistry to assess for liver de-compensation events
Tolerability of the ketogenic diet
Secondary outcome measures
Changes in liver stiffness and steatosis
MRI with proton density fat fraction (PDFF)
Weight loss and change in body composition
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Ketogenic dietActive Control1 Intervention
For participants randomized to the ketogenic diet arm, a consultation with the providers of medically supervised weight loss clinic of Indiana University Health will be arranged. Subjects will be educated on the concepts of ketosis, symptoms associated with it, and dietary manipulation to achieve ketosis. Participants in this arm will use the suggested recipes in combination with strict carbohydrate monitoring though checking for urine ketone bodies. These recipes were gathered and vetted by the dietitian at the medically supervised weight loss clinic. We anticipate that this approach will allow for more calorie intake and easier carbohydrate restriction. The follow up visits will be determined by the providers of the medically supervised weight loss clinic based on the symptoms reported and subject's compliance with carbohydrate restriction.
Group II: Standard of CarePlacebo Group1 Intervention
For participants randomized to this arm, a consultation with the providers of medically supervised weight loss clinic will be arranged. The discussion will focus on portion control using a balanced diet. A follow up visit will be at 16 weeks. This is the extent of interventions received for participants in this arm.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,748 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
2,585 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Raj Vuppalanchi, M.D.5.09 ReviewsPrincipal Investigator - Indiana University
Medical School - Gandhi Medical College and Hospital, Secunderabad, Bachelor of Medicine, Bachelor of Surgery
Long Island College Hospital, Residency in Internal Medicine
1 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
70 Patients Enrolled for Non-alcoholic Fatty Liver Disease
5Patient Review
This doctor was very thorough and provided all the information I needed.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for liver cancer.I do not have any active infections.My liver function is moderately to severely impaired.I have symptoms of delayed stomach emptying.I have had liver surgery in the past.I drink less than 20g (females) or 30g (males) of alcohol daily.I am currently on medication for weight loss or in a weight loss program.I am 18 years old or older.I have heart failure that is not well-managed.I have fluid in my abdomen or have experienced confusion due to liver problems.I have NASH cirrhosis and my BMI is over 30.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Ketogenic diet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in the experiment?
"Affirmative, the information posted on clinicaltrials.gov reveals that this medical experiment is presently looking for new participants. The trial was first published on August 15th 2020 and has been recently updated in November 22nd 2022. 40 individuals are required to be recruited across 1 medical facility."
Answered by AI
Does this research project continue to accept participants?
"Affirmative. According to clinicaltrials.gov, this investigation is actively looking for individuals to join their research team; the study was first announced on August 15th 2020 and last modified November 22nd 2021. Currently, 40 enrollees are needed from 1 medical centre."
Answered by AI
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