Nonalcoholic Fatty Liver DiseasePhase 1/2NCT05010070
The University of Michigan Wellness for Liver Health Study
A Phase 1/2 study testing diet and lifestyle program in people with Nonalcoholic Fatty Liver Disease, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- diet and lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 3 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have regular access to the internet
- MRI with liver steatosis but nor cirrhosis
- Able to consent and follow directions
- No physical limitations
- Physician approval to participate
- Able to attend in-person appointments in Ann Arbor
- Be identified based on information from the Michigan Genomics Initiative (MGI) database
- have elevated liver function tests
Who cannot join
- non-English speaking
- inability to complete baseline measurements
- a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, Cushing's syndrome, etc.)
- pregnant or planning to get pregnant in the next 6 months
- type 1 diabetes
- non-NAFLD causes of elevated liver function tests
Show all 12Show fewer
- planned or history of weight loss surgery
- vegan or vegetarian
- currently enrolled in a weight loss program or other investigative study that might conflict with this research
- taking medications known to cause weight gain or loss
- recent decompensation/hospitalization
- metal implants/inability to receive MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The University of Michigan Wellness Education for Liver Health Study
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).
Read the detailed description
As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- diet and lifestyle program
- Keywords
- nutrition
- 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.
diet and lifestyle programBehavioural
See description of main arm.
| Study group | Role | What they receive |
|---|---|---|
| diet and lifestyle program | Experimental | Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindful eating. Receives: Behavioral: diet and lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
Measured with pre and post MRIs
Measured: 4 months
Secondary outcomes (2)
Change in Liver Stiffness
Change in liver stiffness as measured using Magnetic resonance (MR) elastography
Measured: 4 months
Body Weight Change
Measured with change in body weight
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start31 Aug 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010070
- Sponsor's protocol ID
- HUM00154361
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2021
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Michigan Wellness Education for Liver Health Study
- ClinicalTrials.gov ID
- NCT05010070
- Acronym / sponsor ID
- HUM00154361
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- nutrition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).
Detailed description
As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diet and lifestyle program | Experimental | Behavioral: diet and lifestyle programParticipants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindful eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- have regular access to the internet
- MRI with liver steatosis but nor cirrhosis
- Able to consent and follow directions
- No physical limitations
- Physician approval to participate
Key exclusion criteria (12 listed)
- non-English speaking
- inability to complete baseline measurements
- a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, Cushing's syndrome, etc.)
- pregnant or planning to get pregnant in the next 6 months
- type 1 diabetes
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 |
|---|---|---|
| diet and lifestyle programSee description of main arm. | Behavioural | diet and lifestyle program |
Primary outcome
Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction
Time frame: 4 months
Measured with pre and post MRIs
2 secondary outcomes
Change in Liver Stiffness
Time frame: 4 months
Body Weight Change
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing diet and lifestyle program in people with Nonalcoholic Fatty Liver Disease, run by University of Michigan 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 8 inclusion and 12 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 14 Aug 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction (time frame: 4 months). 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 14 Aug 2023.