Fatty LiverNAFLDNCT00815009
Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
A study testing Mod Fat/Low Processed Carb Diet and Moderate Exercise, Low Fat Diet and Moderate Exercise and Moderate Exercise Only in people with Fatty Liver, run by San Antonio Military Medical Center at 1 site in United States.
Trial summary
Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Mod Fat/Low Processed Carb Diet and Moderate Exercise, Low Fat Diet and Moderate Exercise and Moderate Exercise Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 yrs
- DEERS eligible (DoD beneficiary)
- All participants must plan to be in the area for at least nine months
- Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months
Who cannot join
- Alcohol consumption > 20 g/d or history of alcohol abuse
- Hepatitis A, B, C
- Chronic liver disease of any other etiology
- Fatty acid oxidation disorder (Inborn errors of metabolism)
- Insulin therapy regime for treatment of diabetes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.
- Conditions
- Fatty Liver
- Being tested
- Mod Fat/Low Processed Carb Diet and Moderate Exercise, Low Fat Diet and Moderate Exercise, Moderate Exercise Only
- Keywords
- NAFLD, NASH
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mod Fat/Low Processed Carb Diet and Moderate ExerciseBehavioural
Also called Low Carb / Mod Fat
Follow a moderate fat with low processed carbohydrate diet with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Low Fat Diet and Moderate ExerciseBehavioural
Also called Low Fat
Follow a low fat diet along with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Moderate Exercise OnlyBehavioural
Also called Mod exercise
No special dietary meal plan. Moderate exercise in the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
| Study group | Role | What they receive |
|---|---|---|
| A (Std of Care) | No intervention | Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD). Receives: Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise |
| B (Low Fat) | Experimental | Standard of Care, plus Low Fat Diet and Moderate Exercise Receives: Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise; Behavioral: Low Fat Diet and Moderate Exercise |
| C (Mod Fat) | Experimental | Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise Receives: Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise |
| D (Exercise only) | Experimental | Standard of Care plus Moderate Exercise only Receives: Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise; Behavioral: Moderate Exercise Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
Measured: 6 months
Secondary outcomes (1)
Insulin resistance (IR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Renee E. Cole, San Antonio Military Medical Center
- Investigators
- Renee E Cole, MS, PhD, Principal investigator, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815009
- Sponsor's protocol ID
- C.2008.171
- Acronym
- NAFLD
- Status last verified
- Jul 2012
- First submitted
- 24 Dec 2008
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00815009
- Acronym / sponsor ID
- NAFLD / C.2008.171
- Conditions
- Fatty Liver
- Keywords
- NAFLD, NASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Dec 2008 (estimated)
- 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.
Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A (Std of Care) | No intervention | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate ExerciseStandard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD). |
| B (Low Fat) | Experimental | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise, Behavioral: Low Fat Diet and Moderate ExerciseStandard of Care, plus Low Fat Diet and Moderate Exercise |
| C (Mod Fat) | Experimental | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate ExerciseStandard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise |
| D (Exercise only) | Experimental | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise, Behavioral: Moderate Exercise OnlyStandard of Care plus Moderate Exercise only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 yrs
- DEERS eligible (DoD beneficiary)
- All participants must plan to be in the area for at least nine months
- Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months
Key exclusion criteria (6 listed)
- Alcohol consumption > 20 g/d or history of alcohol abuse
- Hepatitis A, B, C
- Chronic liver disease of any other etiology
- Fatty acid oxidation disorder (Inborn errors of metabolism)
- Insulin therapy regime for treatment of 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 |
|---|---|---|
| Mod Fat/Low Processed Carb Diet and Moderate ExerciseAlso: Low Carb / Mod FatFollow a moderate fat with low processed carbohydrate diet with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks) | Behavioural | A (Std of Care), B (Low Fat), C (Mod Fat), D (Exercise only) |
| Low Fat Diet and Moderate ExerciseAlso: Low FatFollow a low fat diet along with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks) | Behavioural | B (Low Fat) |
| Moderate Exercise OnlyAlso: Mod exerciseNo special dietary meal plan. Moderate exercise in the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks) | Behavioural | D (Exercise only) |
Primary outcome
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
Time frame: 6 months
1 secondary outcome
Insulin resistance (IR)
Time frame: 6 months
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 16 Jul 2012.
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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.
Renee E Cole, MS, PhD principal investigator
San Antonio Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mod Fat/Low Processed Carb Diet and Moderate Exercise, Low Fat Diet and Moderate Exercise and Moderate Exercise Only in people with Fatty Liver, run by San Antonio Military Medical Center 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 6 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 16 Jul 2012. 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?
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) (time frame: 6 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 16 Jul 2012.