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2025/10/15Research Results
FPP Granted U.S. Patent for
"Method of Treating Type 2 Diabetic Patients"
Recognized for Its Role in Immune Support
and Effective Energy Source
We announced in the following press release that FPP acquired a new U.S. patent.
Osato Research Institute (Headquarters: Ibi-gun, Gifu, Japan; President: Yuki Hayashi) is pleased to announce that the results of its clinical study on FPP (Fermented Papaya Preparation) - a fermented food product developed by the Institute - have been officially recognized with the granting of a new U.S. Patent by the United States Patent and Trademark Office (USPTO) for a "Method of Treating Type 2 Diabetic Patients*." This patent is based on scientific evidence demonstrating that FPP enhances immune function in patients with type 2 diabetes by promoting the "respiratory burst", a key component of the innate immune response.
Registration Date: June 10, 2025, Patent Number: US 12,324,822B2
*FPP is a food product composed primarily of carbohydrates and is not a pharmaceutical intended for curative treatment. This patent recognizes the scientific evidence supporting the usefulness of FPP as a complementary food that helps maintain immune function in individuals with type 2 diabetes, despite its carbohydrate-based composition.
The newly granted patent is based on collaborative research conducted with Professor Chandan K. Sen, Director of the McGowan Institute for Regenerative Medicine (MIRM) at the University of Pittsburgh, USA (1). In patients with diabetes, prolonged hyperglycemia is known to impair immune function, leading to delayed wound healing and increased risk of infection. In the United States in particular, the rising prevalence of chronic wounds among diabetic patients and the associated high medical costs have become serious social and healthcare challenges. As a result, the importance of preventive approaches and complementary immune support has gained increasing attention.
Professor Sen and his research tram first confirmed that FPP, despite being a food product primarily composed of carbohydrates, had no adverse effect on blood glucose levels in patients with type 2 diabetes before proceeding with the clinical study. The "respiratory burst" is a biological defense mechanism in which immune cells such as macrophages and neutrophils eliminate invading pathogens by producing a large, short-term surge of reactive oxygen species (ROS) through the activation of NADPH oxidase. This study demonstrated that in patients with type 2 diabetes - who have impaired glucose metabolism and reduced ability to utilize glucose as an energy source - FPP can be safely consumed, functions as an effective energy source within the body, and enhances the respiratory burst, thereby contributing to the improvement of innate immune function.
This achievement had already been granted a Japanese patent in 2018 under the title "ATP Production Promoter, Mitochondrial Activity Promoter, and Immunostimulant". The newly issued U.S. patent further reinforces the scientific validity and usefulness of FPP. The proven safety of FPP and its ability to enhance immune function suggest that it may serve as a novel complementary approach to addressing medical challenges such as immune dysfunctin in chronic diseases, potentially contributing to reductions in healthcare costs and improvements in quality of life (QOL)(2).
For more details on the study, please visit:
https://en.ori-japan.com/research/download/file-2015-1.pdf
Figure 2. Effects of FPP intake in patients with type 2 diabetes: (a) No adverse effect on HbA1c levels (b) Enhancement of short-term ROS production
Figure 3. Effects of FPP intake on monocytes from patients with type 2 diabetes: (a) Enhancement of intracellular ATP (energy) production (b) Activation of NADPH oxidase (c) Activation of mitochondria
■The Dual Role of ROS and the Action of FPP
Reactive Oxygen Species (ROS) have two contrasting aspects: "Bad ROS", which can damage cells, and "Good ROS", which are essential for immune function. Excess accumulation of Bad ROS in the body leads to oxidative stress, a condition known to contribute to chronic inflammation, accelerated ageing, and the onset or progression of diseases such as Alzheimer's disease, diabetes. In contrast, Good ROS are temporarily produced by immune cells when they attack and eliminate pathogens such as viruses and bacteria, playing a vital role in the body's natural defense mechanisms.
FPP helps protect cells and regulate inflammation by suppressing the excessive accumulation of Bad ROS while appropriately promoting the production of Good ROS. Through this dual action - both antioxidant and immunomodulatory - FPP helps reduce excessive inflammatory responses and maintain cellular health. These complex biological effects are associated with the activation of Nrf2, a transcription factor that regulates the body's antioxidant defenses and immune functions/balance. FPP has been granted a Japanese patent as a "Nuclear Nrf2 Level-Increasing Agent".
Previous researches have demonstrated that FPP improves antioxidant and immune functions that decline with age. Osato Research Institute remains committed to advancing further research and applications of FPP to promote healthy ageing and greater efficiency in healthcare in the super-aging society.
■What is FPP (Fermented Papaya Preparation)?
Developed by Osato Research Institute (ORI), FPP is a fermented food made from non-genetically modified papaya using a proprietary long-term fermentation process. Over the past 30 years, ORI has conducted extensive collaborative research with universities and research institutions in Japan, Europe, and the United States. In addition to its established safety, a total of 54 peer-reviewed scientific papers have been published in international journals as of June 2025.
FPP's Patents:
- ATP production promoter, mitochondrial activity promoter, and immunostimulant (Japan, No. 6401792)
- Method for treating electrohypersensitivity with a FPP (U.S., No. US10,993,980 B2)
- Pharmaceutical composition for treating electrohypersensitivity (Japan, No. 7026387)
- Composition for elongating telomeres (Japan, No. 7449588)
- Nuclear Nrf2 level-increasing agent (Japan, No. 7671550)
■Information on the Newly Granted Patent
Patent Number: US 12,324,822B2
Date of Registration: June 10, 2025
Title of Invention: Method of treating type 2 diabetic patients
Inventors: Chandan K. Sen and Yukiyasu Hayashi
■Osato Research Institute
■References
(1) Dickerson R, Banerjee J, ... Roy S (2015). Does oral supplementation of a fermented papaya preparation correct respiratory burst function of innate immune cells in type 2 diabetes mellitus Antioxidants & Redox Signaling 2015 Feb 1;22(4):339-45.
(2) Cervi, J., Rastmanesh, R., ... & He, F. (2024). Comparing fermented food and vitamin E on exercise-mediated Nrf2/ARE activation in middle-aged/elderly: A randomized, double-blind clinical study. Functional Food Science, 4(11): 413-426.