Weight Loss Intervention for Non-alcoholic Fatty Liver Disease

Overseen By Paul Sandoval

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Psychotropic medications

Disqualifiers: Gastrointestinal disorder, Liver disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a specific weight loss program can assist individuals with non-alcoholic fatty liver disease (NAFLD), a condition characterized by fat accumulation in the liver. Researchers seek to determine if this program can enhance liver health in individuals with a genetic marker associated with NAFLD. Participants will adhere to a personalized healthy eating and exercise plan. The trial seeks Mexican or Mexican-American men with a Body Mass Index (BMI) between 30 and 50, who possess the specific genetic marker and have NAFLD. As an unphased study, this trial provides a unique opportunity to contribute to understanding the impact of lifestyle changes on liver health.

Will I have to stop taking my current medications?

The trial requires that participants not take any medication or supplement known to affect body composition or have a history of exposure to drugs that can harm the liver. If your current medications fall into these categories, you may need to stop taking them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lifestyle changes, such as those in a weight loss program, are generally safe and well-tolerated for people with non-alcoholic fatty liver disease (NAFLD). Studies have found that losing weight can improve liver health without causing serious side effects. Specifically, losing about 5% of body weight can lead to significant health benefits for people with NAFLD.

The planned weight loss program includes changes to diet and exercise, which are common and safe ways to manage NAFLD. Participants typically follow nutritional advice and gradually increase their physical activity. This method is designed to be easy to follow and usually does not cause harmful effects. Overall, research supports the safety of lifestyle changes like this, and they are often recommended to improve liver health in people with NAFLD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for non-alcoholic fatty liver disease (NAFLD), which often involve general weight loss programs or medication, the NAFLD-specific weight loss intervention is unique because it tailors its approach specifically to the needs of NAFLD patients. A key feature is the personalized counseling sessions that teach behavioral strategies for healthy eating and physical activity, focusing directly on NAFLD nutritional guidelines. This intervention also provides culturally-tailored meal plans and grocery lists, making dietary changes more accessible and sustainable. Researchers are excited about this method because it addresses the root lifestyle factors of NAFLD in a practical and personalized manner, potentially leading to more effective management of the condition.

What evidence suggests that this weight loss intervention could be effective for NAFLD?

Research shows that lifestyle changes can greatly help people with non-alcoholic fatty liver disease (NAFLD). Studies have found that losing at least 5% of body weight can reduce liver fat. Regular exercise, such as strength training, can also lower liver fat, even without weight loss. Evidence suggests that combining healthy eating and physical activity effectively improves liver health. This trial will evaluate a NAFLD-specific weight loss intervention designed based on these findings. Participants in the wait-list control group will receive the same intervention strategies after study comparisons. ^{6 7 8 9 10}

Who Is on the Research Team?

David O Garcia, PhD

Principal Investigator

University of Arizona, Mel & Enid Zuckerman College of Public Health

Are You a Good Fit for This Trial?

Mexican or Mexican-American men aged 18-64 with Non-alcoholic Fatty Liver Disease (NAFLD) and a specific genetic risk (PNPLA3 CG/GG genotype). Participants must have a BMI of 30 to 50, speak English or Spanish, and be able to consent. Excluded are those who exercise regularly, recently lost weight or plan significant travel; also excluded are individuals with certain medical conditions like viral hepatitis, heavy alcohol use, psychological issues under recent treatment, cardiovascular risks, uncontrolled high blood pressure, gastrointestinal disorders or eating disorders.

Inclusion Criteria

I am a Mexican or Mexican-American man.

I can speak, read, and write in English or Spanish.

Have a CAP score ≥248 at screening

Exclusion Criteria

I am not on medication that affects my body composition or have taken liver-damaging drugs.

I have had weight loss surgery in the past.

I have heart problems like failure, chest pain, or irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a tailored NAFLD-specific weight loss intervention, including 12 weekly individual counseling sessions and self-monitoring of body weight, eating, and physical activity behaviors.

12 weeks

12 visits (in-person)

Follow-up

Participants complete a 12-week follow-up including bi-weekly phone calls, followed by a 6-month follow-up period with no intervention contact.

9 months

Bi-weekly phone calls for 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NAFLD-specific weight loss intervention
• Wait-list control

Trial Overview

The trial is testing a NAFLD-specific weight loss intervention tailored for the participants' cultural background against a wait-list control group. Using an RCT design where two-thirds receive the intervention and one-third waits for later treatment allows comparison of outcomes between active and delayed interventions.

How Is the Trial Designed?

Group I: Wait-list control Experimental Treatment 1 Intervention

The wait-list control group will receive the same intervention strategies described for the NAFLD-specific weight loss intervention after study comparisons have been made.

Group II: NAFLD-specific weight loss intervention Experimental Treatment 1 Intervention

Participants will attend 12 weekly 30-45-minute individual counseling sessions and receive tailored lesson materials focused on behavioral strategies for adopting and maintaining healthy eating and physical activity (PA) behaviors. Participants will self-monitor their body weight, eating, and PA behaviors in a weekly journal. Dietary recommendations will follow nutritional guidelines for the treatment of NAFLD. To facilitate the adoption of the dietary recommendation, participants will be provided culturally-tailored meal plans and grocery lists that allow them to make small, practical dietary changes of \~100 calories. Participants will be prescribed weekly exercise goals with the duration increasing from 15-45 minutes, 5 days/week, over the 12-month program. After the completion of 12 weekly individual counseling sessions, participants will complete a 12-week follow-up including bi-weekly phone calls, followed by a 6-month follow-up period in which no intervention contact is made.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

An 8-week lifestyle modification education program for 82 obese patients with nonalcoholic fatty liver disease (NAFLD) led to significant reductions in weight, body mass index, and body fat mass compared to a control group.

The intervention also resulted in a notable decrease in total calorie intake, suggesting that lifestyle education can be an effective strategy for improving body composition in NAFLD patients, although physical activity levels did not significantly change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Lifestyle Modification Education on Adiposity Measures in Overweight and Obese Nonalcoholic Fatty Liver Disease Patients. Arab, A., Askari, G., Golshiri, P., et al.[2022]

A 12-month multidisciplinary lifestyle intervention for patients with nonalcoholic fatty liver disease (NAFLD) resulted in significant weight loss, with 92.2% of participants maintaining a lower weight compared to baseline, compared to only 50% in the conventional treatment group.

Patients in the multidisciplinary treatment group experienced an average weight reduction of 4.2 kg and significant improvements in liver enzymes, highlighting the efficacy of a structured dietary plan over standard recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAFLD Nutritional Management: Results from a Multidisciplinary Approach. Policarpo, SRO., Machado, MV., Barreira, D., et al.[2022]

Lifestyle interventions, including calorie restriction and exercise, are beneficial for improving metabolic syndrome features and surrogate markers of non-alcoholic fatty liver disease (NAFLD), which affects about one-third of the Western population.

There is a lack of long-term studies (most under 12 months) and histological evidence to conclusively demonstrate the effectiveness of these interventions on the actual liver tissue, indicating a need for further research with extended follow-up periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for the treatment of non-alcoholic fatty liver disease. Bradford, V., Dillon, J., Miller, M.[2021]

A 10-week diet plus exercise program significantly improved liver health and overall fitness in patients with nonalcoholic fatty liver disease (NAFLD), showing better results than exercise alone.

While both diet-plus-exercise and exercise-only programs improved health markers like body weight and insulin sensitivity, only the diet-plus-exercise group showed significant improvements in liver biochemistry, highlighting its greater efficacy in treating NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. Chen, SM., Liu, CY., Li, SR., et al.[2022]

In a study of 71 patients with non-alcoholic fatty liver disease (NAFLD) and dyslipidaemia, weight loss was linked to improvements in liver enzyme levels, indicating that weight loss can positively affect NAFLD.

Dietary advice did not lead to weight loss but did improve cholesterol levels, and statins were found to be safe, with only 15.4% of patients experiencing a temporary increase in liver enzymes, suggesting they are effective for managing dyslipidaemia in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss, dietary advice and statin therapy in non-alcoholic fatty liver disease: a retrospective study. Riley, P., Sudarshi, D., Johal, M., et al.[2014]

A scoping review of 28 studies on behavioral weight-loss interventions for patients with NAFLD found that successful programs typically resulted in an average weight loss of at least 5% and included features like biweekly counseling and specific activity targets.

Retention rates were highest for telephone-based interventions, while face-to-face programs had lower retention, particularly among younger women and those with multiple metabolic conditions, indicating a need for tailored approaches to improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral weight-loss interventions for patients with NAFLD: A systematic scoping review. Balakrishnan, M., Liu, K., Schmitt, S., et al.[2023]

An intensive weight-loss intervention over 6 months led to a significant normalization of ALT levels in 66.7% of patients with NAFLD compared to 18.2% in the control group, indicating some efficacy in liver enzyme improvement.

Despite some positive changes in liver enzymes and weight loss, the overall treatment outcomes for NAFLD did not show significant improvement, suggesting the need for larger trials to explore more effective weight-loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intensive weight-loss intervention on metabolic, ultrasound and anthropometric parameters among patients with obesity and non-alcoholic fatty liver disease: an RCT. Arora, C., Malhotra, A., Ranjan, P., et al.[2022]

In a review of 15 randomized controlled trials involving both adults and children, metformin showed a significant effect on normalizing alanine transaminase levels compared to vitamin E, indicating its potential efficacy in treating nonalcoholic fatty liver disease (NAFLD).

While some treatments like pioglitazone showed reduced liver necrosis and inflammation, the overall limited data and methodological issues in the studies prevent definitive conclusions about the efficacy of various pharmacological and dietary interventions for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. Socha, P., Horvath, A., Vajro, P., et al.[2022]

Lifestyle changes, particularly optimizing nutrition and increasing physical activity, are crucial for improving or resolving non-alcoholic fatty liver disease (NAFLD).

Among various dietary interventions studied in 317 adults with NAFLD, the Mediterranean Diet showed the most significant reductions in liver fat and weight loss, indicating its potential effectiveness, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Dietary Approaches for the Treatment of Non-Alcoholic Fatty Liver Disease: A Systematic Review. Saeed, N., Nadeau, B., Shannon, C., et al.[2020]

A 12-week study involving 88 Chinese females with nonalcoholic fatty liver disease (NAFLD) showed that a Mediterranean-like diet led to significant weight loss and reductions in liver fat content, with the diet group losing an average of 4.0 kg compared to only 1.5 kg in the control group.

Supplementation with pentadecanoic acid (C15:0) further improved health outcomes by lowering LDL-cholesterol and positively affecting gut microbiome composition, indicating that this dietary approach can enhance metabolic health in individuals with NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: The TANGO randomized controlled trial. Chooi, YC., Zhang, QA., Magkos, F., et al.[2023]

An 8-week resistance exercise program in sedentary adults with non-alcoholic fatty liver disease (NAFLD) resulted in a significant 13% reduction in liver lipid levels, demonstrating its efficacy in managing NAFLD without requiring weight loss.

The study also showed improvements in lipid oxidation, glucose control, and insulin resistance, indicating that resistance exercise can positively affect liver health and metabolic parameters independent of changes in body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss. Hallsworth, K., Fattakhova, G., Hollingsworth, KG., et al.[2022]

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