Soy Milk for Non-alcoholic Fatty Liver Disease

Overseen By Ann Popelar

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Marialena Mouzaki

Disqualifiers: Soy allergy, Cow's milk allergy, Recent antibiotics, Endocrine disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are being treated for existing endocrine disorders, you may not be eligible to participate.

What data supports the effectiveness of soy milk as a treatment for non-alcoholic fatty liver disease?

Research suggests that soy milk and its components, like soy isoflavones, may help improve liver health in non-alcoholic fatty liver disease by enhancing metabolic parameters and reducing liver fat. Studies in both animals and humans have shown that soy can positively affect liver function and reduce oxidative stress, which is beneficial for managing this condition. ^{1 2 3 4 5}

Is soy milk safe for humans?

The studies reviewed do not report any specific safety concerns about soy milk or soy isoflavones in humans, suggesting it is generally safe for consumption. ^{1 2 3 4 6}

How does soy milk treatment differ from other treatments for non-alcoholic fatty liver disease?

Soy milk is unique for non-alcoholic fatty liver disease because it contains soy isoflavones, which have been shown to improve metabolic parameters and reduce liver fat accumulation through natural pathways, unlike other treatments that may not focus on dietary components. ^{1 2 4 6 7}

What is the purpose of this trial?

A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.

Eligibility Criteria

This trial is for children with non-alcoholic fatty liver disease (NAFLD) who are overweight or obese. They must have an MRI PDFF >10% and elevated ALT levels (>22 for females, >26 for males).

Inclusion Criteria

I have NAFLD or my ALT levels are high for my sex.

I have NAFLD with a liver fat level over 10% on MRI.

My child is overweight or obese.

Exclusion Criteria

Baseline habitual (>3 days per week) consumption of soy foods

I have taken antibiotics in the last 8 weeks.

MRI-PDFF <10%

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either standard soy milk or 2% fat cow's milk twice daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Soy Milk

Trial Overview The study compares the effects of drinking standard soy milk versus 2% fat cow's milk on the severity of NAFLD in children. It aims to see if soy isoflavones in soy milk can help reduce liver disease.

Participant Groups

Group I: Standard Soy Milk Experimental Treatment 1 Intervention

Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.

Group II: 2% Fat Cows Milk Placebo Group 1 Intervention

Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.

Who Is Running the Clinical Trial?

Marialena Mouzaki

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

In a study of 70 patients with nonalcoholic fatty liver disease (NAFLD), those who consumed 240 ml of soy milk daily for 8 weeks showed a significant reduction in serum alanine aminotransferase (ALT) and high-sensitivity C-reactive protein (hs-CRP) compared to a control group on a low-calorie diet.

While soy milk improved certain metabolic parameters, it did not lead to significant changes in fatty liver grade or other liver enzymes, indicating that while beneficial, soy milk may not address all aspects of NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Soy Milk on Metabolic Status of Patients with Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. Eslami, O., Shidfar, F., Maleki, Z., et al.[2020]

In a study involving 66 patients with non-alcoholic fatty liver disease (NAFLD), those who consumed 240 ml of soy milk daily for 8 weeks showed significant improvements in insulin levels, insulin resistance (HOMA-IR), and blood pressure compared to a control group on a calorie-restricted diet.

The soy milk group experienced a notable reduction in both systolic and diastolic blood pressure, as well as an increase in the QUICKI index, indicating improved insulin sensitivity, highlighting the potential of soy milk as a dietary intervention for managing NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of soy milk consumption on glycemic status, blood pressure, fibrinogen and malondialdehyde in patients with non-alcoholic fatty liver disease: a randomized controlled trial. Maleki, Z., Jazayeri, S., Eslami, O., et al.[2019]

A systematic review of five randomized controlled trials indicates that a soy diet significantly reduces insulin resistance in patients with nonalcoholic fatty liver disease, as evidenced by a notable decrease in HOMA-IR scores.

While the soy diet showed benefits in insulin resistance, it did not have a significant impact on other health markers such as body mass index, liver enzymes, or cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy diet for nonalcoholic fatty liver disease: A meta-analysis of randomized controlled trials. Xiong, P., Zhu, YF.[2023]

In a study involving 42 Zucker rats, those fed a soy protein concentrate diet with high isoflavones showed significantly reduced liver fat accumulation (steatosis) compared to those on a control diet, indicating that higher isoflavone levels provide better protection against non-alcoholic fatty liver disease (NAFLD).

Both obese groups (low and high isoflavones) had lower liver steatosis scores compared to the control group, suggesting that soy protein concentrate can be beneficial for liver health, especially in obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet Containing Soy Protein Concentrate With Low and High Isoflavones for 9 Weeks Protects Against Non-alcoholic Fatty Liver Steatosis Using Obese Zucker Rats. Hakkak, R., Spray, B., Børsheim, E., et al.[2022]

Soybean has shown significant potential in improving liver function and reducing fatty liver indicators in both preclinical studies (involving 212 animals) and clinical trials (with 260 patients), suggesting it may be an effective treatment for non-alcoholic fatty liver disease (NAFLD).

The protective effects of soybean on the liver are linked to its ability to regulate lipid metabolism and oxidative stress through the Akt/AMPK/PPARα signaling pathway, highlighting its mechanism of action in combating NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical and clinical evidence for the treatment of non-alcoholic fatty liver disease with soybean: A systematic review and meta-analysis. Li, Y., Deng, X., Guo, X., et al.[2023]

Isoflavones, natural compounds found in soy, have shown potential in preventing non-alcoholic fatty liver disease (NAFLD) and pathological adiposity by suppressing the ChREBP signaling pathway, which is involved in fat production.

They also activate Wnt signaling through estrogen receptors, which helps reduce fat cell formation by degrading key proteins involved in adipogenesis, suggesting a dual mechanism of action for isoflavones in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isoflavones as a smart curer for non-alcoholic fatty liver disease and pathological adiposity via ChREBP and Wnt signaling. Kim, MH., Kang, KS.[2023]

Non-alcoholic fatty liver disease (NAFLD) affects about 25% of the global population, primarily due to obesity and diabetes, and currently has no direct pharmacological treatments, making dietary intervention crucial.

Soy consumption has been shown to reduce lipid accumulation in the liver and improve metabolic syndrome associated with NAFLD, likely through mechanisms involving key transcription factors that regulate fat metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypolipidemic Effects of Soy Protein and Isoflavones in the Prevention of Non-Alcoholic Fatty Liver Disease- A Review. Xiao, CW., Hendry, A.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Soy Milk on Metabolic Status of Patients with Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. [2020]

2. Scotland pubmed.ncbi.nlm.nih.gov

Effect of soy milk consumption on glycemic status, blood pressure, fibrinogen and malondialdehyde in patients with non-alcoholic fatty liver disease: a randomized controlled trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Soy diet for nonalcoholic fatty liver disease: A meta-analysis of randomized controlled trials. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Diet Containing Soy Protein Concentrate With Low and High Isoflavones for 9 Weeks Protects Against Non-alcoholic Fatty Liver Steatosis Using Obese Zucker Rats. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Preclinical and clinical evidence for the treatment of non-alcoholic fatty liver disease with soybean: A systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Isoflavones as a smart curer for non-alcoholic fatty liver disease and pathological adiposity via ChREBP and Wnt signaling. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Hypolipidemic Effects of Soy Protein and Isoflavones in the Prevention of Non-Alcoholic Fatty Liver Disease- A Review. [2022]