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Behavioral Intervention

Diet Intervention for Liver Disease

Q: Are participants still being enrolled in this research project?

<p>Indeed, clinicaltrials.gov provides evidence that this medical trial is still in search of volunteers. It was initially posted on May 18th 2022 and recently amended on June 21st 2022 - with a goal to recruit 100 patients from one location.</p>

Q: What is the present enrollment capacity of this medical trial?

<p>Affirmative. Per the data on clinicaltrials.gov, this medical trial is currently recruiting patients who qualify for participation. The study was initially uploaded on May 18th 2022 and most recently updated June 21st 2022; they are looking to enroll 100 individuals from a single site.</p>

N/A

Recruiting

Led By Andreana Haley, PhD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 40 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. the liver 1h mrs scans will happen during visit 3 (baseline) and visit 4 (at least 2 weeks on the diet).

Awards & highlights

Study Summary

This trial will test whether a brief diet intervention can improve brain and liver function in people with liver disease.

Who is the study for?

This trial is for English-speaking adults over 40 with fatty liver disease or pre-diabetes who haven't been on a low-carb diet or weight loss program in the last 6 months. Participants must have at least a 5% hepatic triglyceride level. Those with MRI contraindications, neurological diseases, severe psychiatric illness, high alcohol use, or morbid obesity cannot join.Check my eligibility

What is being tested?

The study tests if a short-term (up to three weeks) dietary intervention can improve brain and liver health in people with fatty liver disease and/or pre-diabetes. It aims to see how changing what you eat affects your body's organs.See study design

What are the potential side effects?

Since this is a diet intervention trial, side effects may include changes in digestion like constipation or diarrhea, possible nutrient deficiencies if not balanced properly, and temporary symptoms from adjusting to new eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 40 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. the liver 1h mrs scans will happen during visit 3 (baseline) and visit 4 (at least 2 weeks on the diet).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. the liver 1h mrs scans will happen during visit 3 (baseline) and visit 4 (at least 2 weeks on the diet).

This trial's timeline: 3 weeks for screening, Varies for treatment, and liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. the liver 1h mrs scans will happen during visit 3 (baseline) and visit 4 (at least 2 weeks on the diet). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decrease in Liver Fat

Brain Concussion

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low-carbohydrate dietExperimental Treatment1 Intervention

Participants assigned to the Low-carbohydrate diet will be instructed to limit carbohydrate intake to <30 g/d.

Group II: Low-calorie dietActive Control1 Intervention

Participants assigned to the Low-calorie diet will be instructed to reduce their energy intake to match the LoCHO block (we are predicting ~1200 kcal/d for women and ~1500 kcal/d for men, following current recommendations for treatment of NAFLD).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diet Intervention

2021

N/A

~290

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor

353 Previous Clinical Trials

81,144 Total Patients Enrolled

7 Trials studying Metabolic Syndrome

376 Patients Enrolled for Metabolic Syndrome

Andreana Haley, PhDPrincipal InvestigatorDepartment of Psychology, University of Texas at Austin

3 Previous Clinical Trials

241 Total Patients Enrolled

Media Library

Diet Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05216796 — N/A

Metabolic Syndrome Research Study Groups: Low-carbohydrate diet, Low-calorie diet

Metabolic Syndrome Clinical Trial 2023: Diet Intervention Highlights & Side Effects. Trial Name: NCT05216796 — N/A

Diet Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05216796 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled in this research project?

"Indeed, clinicaltrials.gov provides evidence that this medical trial is still in search of volunteers. It was initially posted on May 18th 2022 and recently amended on June 21st 2022 - with a goal to recruit 100 patients from one location."

Answered by AI

What is the present enrollment capacity of this medical trial?

"Affirmative. Per the data on clinicaltrials.gov, this medical trial is currently recruiting patients who qualify for participation. The study was initially uploaded on May 18th 2022 and most recently updated June 21st 2022; they are looking to enroll 100 individuals from a single site."

Answered by AI