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Stevia for Fatty Liver Disease

N/A

Recruiting

Led By Rohit Kohli, MBBS, MS

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 to 8 weeks (cm)

Awards & highlights

Study Summary

This trial will test whether Rebaudioside, a natural sweetener, can be used to treat adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by decreasing alanine aminotransferase (ALT) levels.

Who is the study for?

This trial is for adolescents aged 10-18 with Non-alcoholic Fatty Liver Disease (NAFLD), specifically those who have more than the normal amount of fat in their liver and elevated ALT levels, indicating liver inflammation. Participants must be overweight but not suffering from other major illnesses, not pregnant, haven't used antibiotics recently, and don't smoke or drink.Check my eligibility

What is being tested?

The Super HEROES study is testing if a natural sweetener called Rebaudioside can help treat NAFLD in teens by lowering ALT levels. Over 8 weeks, participants will randomly receive either standard care, water only, or water mixed with Rebaudioside to see which helps reduce liver fat the most.See study design

What are the potential side effects?

Since this trial involves dietary interventions like water and stevia (Rebaudioside), side effects are expected to be minimal. However, some individuals might experience digestive changes or allergic reactions to stevia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 to 8 weeks (%)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 to 8 weeks (%)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to 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

Change in Alanine Transaminase (ALT)

Secondary outcome measures

Change in Acanthosis nigricans skin exam

Change in Fat percentage

Change in Glucose Level

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Stevia InterventionExperimental Treatment1 Intervention

We will order and deliver a commercially-available stevia-sweetened soft drink Zevia (Los Angeles, CA) to each participant in the treatment group. We will provide each participant with a weekly supply of 24 12 fl oz single-serving containers. Zevia will be provided in an assortment of flavors for the first week, then catered to the preference of the participant for the remainder of the study. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously. Participants will also be asked to keep track of how many containers they consume using a sticker chart, and we will also phone parents weekly to verify the sticker charts

Group II: Water InterventionActive Control1 Intervention

We will order and deliver bottled water to the homes of subjects in the treatment group. We will provide each participant with a weekly supply of about 36 16.9 fl oz single-serving containers. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously.

Group III: Standard of CareActive Control1 Intervention

The control group will receive standard of care dietary advice for their solid food and beverage intake.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

231 Previous Clinical Trials

5,076,568 Total Patients Enrolled

Rohit Kohli, MBBS, MSPrincipal InvestigatorChildren's Hospital Los Angeles

Tania Mitsinikos, MDPrincipal Investigator - Children's Hospital Los Angeles

Children's Hospital Los Angeles

Media Library

Stevia Intervention (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03985020 — N/A

Non-alcoholic Fatty Liver Disease Research Study Groups: Stevia Intervention, Water Intervention, Standard of Care

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Stevia Intervention Highlights & Side Effects. Trial Name: NCT03985020 — N/A

Stevia Intervention (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03985020 — N/A

Frequently Asked Questions

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

Are senior citizens precluded from participating in this experiment?

"This medical study is enrolling participants between the ages of 10 and 18."

Answered by AI

Might I be a suitable candidate to join this experiment?

"In order to be accepted into this research trial, individuals must have a form of liver disease and fall within the prescribed age range of 10-18 years old. Currently, the team is seeking 60 participants for their study."

Answered by AI

What is the current size of this research endeavor?

"Indeed, the clinicaltrial.gov portal confirms that this medical trial is actively enrolling participants. The original posting date was July 26th 2019 and it had been most recently updated on June 13th 2022. 60 patients are required for the single site involved in this study."

Answered by AI

Are there any vacancies for volunteers in this medical trial?

"Yes, the details available on clinicaltrials.gov suggest that this trial is actively seeking enrolment. It was first published on July 26th 2019 and revised most recently June 13th 2022 with a requirement for 60 patients from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis

Tania Mitsinikos 2019. "Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03985020.