Toy Medical Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto Prefecture; President and CEO: Hidenori Takeshita) has confirmed through human clinical trials that alginate intake suppresses the absorption of salt (sodium) from food. The paper on these findings has been published in "Pharmacology and Therapeutics (2022, Vol. 50, No. 10, pp. 1829-1836)".

■Background

Excessive salt intake is known to increase the risk of lifestyle-related diseases such as hypertension, heart disease, cerebrovascular disease, and chronic kidney disease. The "Dietary Reference Intakes for Japanese (2020 Edition)" indicates that the recommended daily salt intake is less than 7.5 g for healthy adult men and less than 6.5 g for women*1, but the Ministry of Health, Labour and Welfare's 2019 National Health and Nutrition Survey Report indicates that the actual salt intake for adult men is 10.9 g/day and for women is 9.3 g/day, significantly exceeding the target values*2.

Our company is engaged in research and development related to inhibiting salt absorption, and to date we have obtained patents for foods that inhibit salt absorption using alginates*3 and have verified the salt absorption inhibiting effect in animal experiments*4. Therefore, in order to clarify the salt absorption inhibiting effect of alginates in humans, we conducted a clinical trial to evaluate the effect on salt absorption in the body when alginates are ingested for a certain period of time in healthy adult males.

■ Overview of the clinical trial

In a placebo-controlled, randomized, double-blind, crossover comparative study*5, 30 healthy Japanese men aged 20 or older were divided into two groups: one group consuming alginates-containing foods and the other consuming a placebo. The effect of consuming 675 mg of alginates daily for 4 days at dinner was evaluated by measuring the amount of sodium excreted in urine over a 24-hour period, after adjusting for dietary salt intake.

In the crossover study analysis, a carryover effect was observed in the change in sodium excreted in urine from before intake of the test food (Δsodium amount). Therefore, when the analysis was performed using a placebo-controlled, randomized, parallel-group comparative study design with data from the first trial, the group consuming alginates-containing foods showed significantly lower Δsodium amounts compared to the placebo food group (Figure). This suggests that alginates suppress the absorption of salt from food into the body, thereby reducing the amount of sodium excreted in urine.

The clinical trial results described above suggest that alginate intake may suppress the absorption of salt from food.

Through our research and development of unique salt absorption suppression technology, we will continue our activities from Kumamoto to contribute to the wellness of people around the world.

*1 Ministry of Health, Labour and Welfare, "Dietary Reference Intakes for Japanese" (2020 Edition), Ministry of Health, Labour and Welfare, (2019).

*2 Summary of the 2019 National Health and Nutrition Survey Results, Ministry of Health, Labour and Welfare, (2019).

*3 Patent No. 6497764, Food composition for the purpose of sodium excretion

*4 Y. Fujiwara et al., Heliyon, 7(3), e06551 (2021).

*5 A method in which subjects are randomly divided into two groups, evaluated without knowing which test food each group is eating, and then the test foods for each group are swapped and evaluated again. A testing method in which neither the tester nor the subjects know which test food they are eating.

[Contact information for inquiries regarding this matter]

Toy Medical Co., Ltd. Contact Person: Tashiro

TEL: 096-281-0007 FAX: 096-281-0008

Mail：info@toymedical.jp