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Dietary Supplement

Very Low Calorie Diet for Non-alcoholic Fatty Liver Disease

Q: Is this research examining participants that are more than 25 years of age?

This research is looking for participants between the ages of 21 and 70.

Q: Who meets the eligibility criteria for this research project?

This study, which centers around non-alcoholic fatty liver disease (NAFLD), is enrolling 25 qualified candidates between the ages of 21 and 70. There are two additional requirements: a body mass index ranging from 30 to 50 kg/m2, as well as no gender bias in recruitment.

Q: What detrimental effects might result from a patient adhering to an extremely restricted dietary regimen?

Owing to limited clinical data, our team assigned Dietary intervention with very low calorie <a href="https://www.withpower.com/clinical-trials/diet">diet</a> a safety score of 1 on the scale from 1 to 3.

Q: Is recruitment ongoing for this exploration?

According to the information hosted by clinicaltrials.gov, this research project is not currently recruiting patients. Initially posted on July 1st 2022 and last updated on May 31st 2022, there are presently 253 other studies seeking enrolment at this moment in time.

Phase 1

Recruiting

Led By Marcelo L Correia, MD PhD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

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

Must have

BMI ≥ 30 kg/m2 and ≤ 50 kg/m2

Male and female subjects with age ≥ 18 years old and < 70 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial is testing whether a very low-calorie diet can help improve non-alcoholic fatty liver disease (NAFLD) by reducing liver steatosis (fatty infiltration) and fibrosis (scarring). If successful, this could establish the diet as a clinically effective option for treating NAFLD, particularly for patients who are ineligible or don't have access to bariatric surgery.

Who is the study for?

This trial is for adults aged 18-70 with obesity (BMI between 30 and 50) and non-alcoholic fatty liver disease, confirmed by imaging or specific elastography scores. Participants must not have viral hepatitis, autoimmune hepatitis, uncontrolled thyroid issues, severe alcohol use, certain heart conditions, type 1 diabetes or insulin-using type 2 diabetes, significant kidney disease or other serious health problems.Check my eligibility

What is being tested?

The study tests if a very low calorie diet (VLCD), which limits intake to about 800-960 calories per day through meal replacements, can reduce fat and fibrosis in the liver compared to a lower calorie diet. The effects on micro RNAs related to NAFLD pathophysiology will also be explored.See study design

What are the potential side effects?

Potential side effects of VLCD may include fatigue due to energy deficit; nutrient deficiencies if not properly managed; digestive changes like constipation; gallstones from rapid weight loss; and possible mood swings or irritability.

Eligibility Criteria

Inclusion Criteria

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

Select...

My BMI is between 30 and 50.

Select...

I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Liver fibrosis

Liver steatosis

Secondary outcome measures

Fecal microbiome

Micro RNA (miRNA)

Platelet function

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Very Low Calorie Diet ArmExperimental Treatment1 Intervention

We plan to perform a controlled, non-randomized, open-label, pilot clinical trial to evaluate the effect of an 8-week VLCD intervention on NAFLD.

Group II: Control ArmExperimental Treatment1 Intervention

The control group will consume a lower calorie diet and will be instructed to reduce their usual intake of normally consumed foods by up to 500 kcal per day but no less than 1200 kcal per day.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

447 Previous Clinical Trials

879,702 Total Patients Enrolled

Marcelo L Correia, MD PhDPrincipal InvestigatorUniversity of Iowa

Media Library

Very low calorie diet (VLCD) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04861571 — Phase 1

Non-alcoholic Fatty Liver Disease Research Study Groups: Control Arm, Very Low Calorie Diet Arm

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Very low calorie diet (VLCD) Highlights & Side Effects. Trial Name: NCT04861571 — Phase 1

Very low calorie diet (VLCD) (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861571 — Phase 1

Frequently Asked Questions

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

Is this research examining participants that are more than 25 years of age?

"This research is looking for participants between the ages of 21 and 70."

Answered by AI

Who meets the eligibility criteria for this research project?

"This study, which centers around non-alcoholic fatty liver disease (NAFLD), is enrolling 25 qualified candidates between the ages of 21 and 70. There are two additional requirements: a body mass index ranging from 30 to 50 kg/m2, as well as no gender bias in recruitment."

Answered by AI

What detrimental effects might result from a patient adhering to an extremely restricted dietary regimen?

"Owing to limited clinical data, our team assigned Dietary intervention with very low calorie diet a safety score of 1 on the scale from 1 to 3."

Answered by AI

Is recruitment ongoing for this exploration?

"According to the information hosted by clinicaltrials.gov, this research project is not currently recruiting patients. Initially posted on July 1st 2022 and last updated on May 31st 2022, there are presently 253 other studies seeking enrolment at this moment in time."

Answered by AI

Recent research and studies

GutJournal

Mirnas and NAFLD: From Pathophysiology to Therapy

Gjorgjieva, Monika, Cyril Sobolewski, Dobrochna Dolicka, Marta Correia de Sousa, and Michelangelo Foti. 2019. “Mirnas and NAFLD: From Pathophysiology to Therapy”. Gut. BMJ. doi:10.1136/gutjnl-2018-318146.

HepatologyJournal

Salivary Microbiota Reflects Changes in Gut Microbiota in Cirrhosis with Hepatic Encephalopathy

Bajaj, Jasmohan S., Naga S. Betrapally, Phillip B. Hylemon, Douglas M. Heuman, Kalyani Daita, Melanie B. White, Ariel Unser, et al.. 2015. “Salivary Microbiota Reflects Changes in Gut Microbiota in Cirrhosis with Hepatic Encephalopathy”. Hepatology. Wiley. doi:10.1002/hep.27819.

NutritionJournal

Efficacy and Safety of Very-low-calorie Diet in Taiwanese: A Multicenter Randomized, Controlled Trial

Lin, Wen-Yuan, Chih-Hsing Wu, Nain-Feng Chu, and Chih-Jen Chang. 2009. “Efficacy and Safety of Very-low-calorie Diet in Taiwanese: A Multicenter Randomized, Controlled Trial”. Nutrition. Elsevier BV. doi:10.1016/j.nut.2009.02.008.

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