Non-Alcoholic Fatty Liver DiseaseNCT03985020
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
A study testing Stevia Intervention and Water Intervention in people with Non-Alcoholic Fatty Liver Disease, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions: 1. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Stevia Intervention and Water Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 10-18 years
- ALT > 45 IU/L (twice the normal amount)
- BMI >85%
- Fat >5% and kPa> 2.7
Who cannot join
- Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity.
- Familial hyperlipidemia
- Positive hepatitis lab
- Antibiotics within 1 month of beginning the study
- Physical, mental, or cognitive issues preventing participation
- Pregnancy
- Smoking or drinking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Los Angeles
Los Angeles, California, 90027
About this study
In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions:
- Standard of care
- Water delivery
- Water with Rebaudioside (stevia natural sweetener)
Read the detailed description
Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments.
Intervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions:
- Standard of Care
- Water Delivery
- Water with Rebaudioside (Stevia Natural Sweetener)
Objectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Stevia Intervention, Water Intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stevia InterventionOther
We will use commercially available stevia sweetened soft drink Zevia.
Water InterventionOther
Bottled Water
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The control group will receive standard of care dietary advice for their solid food and beverage intake. |
| Water Intervention | Active comparator | 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. Receives: Other: Water Intervention |
| Stevia Intervention | Experimental | 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 Receives: Other: Stevia Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alanine Transaminase (ALT)
A fasting blood sample will be taken at baseline and week 8 and assess change over time in all 3 groups
Measured: Week 1 to week 8 (IU/L)
Secondary outcomes (9)
Change in Fat percentage
Measured using DEXA
Measured: week 1 to 8 weeks (%)
Change in kPA levels
Measured using MR elastography (non-sedated study)
Measured: week 1 to 8 weeks (kPA)
Change in Height
Height will be measured in duplicate within .5cm.
Measured: week 1 to 8 weeks (cm)
Change in Weight
Measured using an electric scale.
Measured: week 1 to 8 weeks (kg)
Change in Waist Circumference
Hip-to-waist ratio will be calculated using a measuring tape that does not stretch, measuring twice at hip-level and twice at waist-level and averaging the results
Measured: week 1 to 8 weeks (cm)
Change in Acanthosis nigricans skin exam
An Acanthosis Nigricans (AN) skin exam will be performed at each visit. Acanthosis Nigricans is an indicator for disorders of insulin resistance.
Measured: week 1 to 8 weeks
Change in Triglyceride levels
measured by fasting blood sample
Measured: week 1 to 8 weeks
Change in Glucose Level
Measured by fasting blood samples
Measured: Week 1 to week 8 (mg/dl)
Change in Insulin Level
Measured by fasting blood sample
Measured: Week 1 to week 8 (UIU/mL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start26 Jul 2019
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three possible groups.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Mitsinikos, Children's Hospital Los Angeles
- Investigators
- Tania Mitsinikos, MD, Principal investigator, Children's Hospital Los AngelesRohit Kohli, MBBS, MS, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985020
- Sponsor's protocol ID
- CHLA-19-00212
- Status last verified
- Sep 2024
- First submitted
- 6 Jun 2019
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
- ClinicalTrials.gov ID
- NCT03985020
- Acronym / sponsor ID
- CHLA-19-00212
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions:
- Standard of care
- Water delivery
- Water with Rebaudioside (stevia natural sweetener)
Detailed description
Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments.
Intervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions:
- Standard of Care
- Water Delivery
- Water with Rebaudioside (Stevia Natural Sweetener)
Objectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three possible groups.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The control group will receive standard of care dietary advice for their solid food and beverage intake. |
| Water Intervention | Active comparator | Other: Water InterventionWe 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. |
| Stevia Intervention | Experimental | Other: Stevia InterventionWe 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 |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 10-18 years
- ALT > 45 IU/L (twice the normal amount)
- BMI >85%
- Fat >5% and kPa> 2.7
Key exclusion criteria (7 listed)
- Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity.
- Familial hyperlipidemia
- Positive hepatitis lab
- Antibiotics within 1 month of beginning the study
- Physical, mental, or cognitive issues preventing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stevia InterventionWe will use commercially available stevia sweetened soft drink Zevia. | Other | Stevia Intervention |
| Water InterventionBottled Water | Other | Water Intervention |
Primary outcome
Change in Alanine Transaminase (ALT)
Time frame: Week 1 to week 8 (IU/L)
A fasting blood sample will be taken at baseline and week 8 and assess change over time in all 3 groups
9 secondary outcomes
Change in Fat percentage
Time frame: week 1 to 8 weeks (%)
Change in kPA levels
Time frame: week 1 to 8 weeks (kPA)
Change in Height
Time frame: week 1 to 8 weeks (cm)
Change in Weight
Time frame: week 1 to 8 weeks (kg)
Change in Waist Circumference
Time frame: week 1 to 8 weeks (cm)
Change in Acanthosis nigricans skin exam
Time frame: week 1 to 8 weeks
Change in Triglyceride levels
Time frame: week 1 to 8 weeks
Change in Glucose Level
Time frame: Week 1 to week 8 (mg/dl)
Change in Insulin Level
Time frame: Week 1 to week 8 (UIU/mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Mitsinikos, MD principal investigator
Children's Hospital Los Angeles
Rohit Kohli, MBBS, MS principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stevia Intervention and Water Intervention in people with Non-Alcoholic Fatty Liver Disease, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alanine Transaminase (ALT) (time frame: Week 1 to week 8 (IU/L)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.