CLINICAL TRIAL article
Front. Nutr.
Sec. Nutrition, Psychology and Brain Health
Volume 12 - 2025 | doi: 10.3389/fnut.2025.1605525
This article is part of the Research TopicBrain Health Across the Lifespan: Nutritional Interventions and Physical Exercise for Healthy AgingView all 5 articles
Effects of Oral Nutritional Supplements plus Mature Silkworm pill on Cognitive Function in Korean Adults with Mild Cognitive Impairment: A 12-Week Randomized Blinded Clinical Trial
Provisionally accepted
Min Ji Kim1
Sun Min Lee2Kyunghwa Sun2Yeon Hee Kim1Ye Jin Seo1Sun Ah Park2Hyoung Su Park3Hye-Jin Kim3
Yoo Park1*
So Young Moon2*- 1Kyunghee University, Yongin, Republic of Korea
- 2Ajou University Hospital, Suwon, Gyeonggi, Republic of Korea
- 3Maeil Health Nutrition Co., Ltd, Pyeongtaek, Republic of Korea
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Objective: This study aimed to determine whether mature silkworm pills plus commercial oral nutritional supplements (ONS) could improve cognitive function, especially in individuals with mild cognitive impairment (MCI). Methods: A total of 62 participants (70.6±8.5 years, 48.4% female), aged≥50 years diagnosed with mild cognitive impairment but not dementia, were randomly assigned into the 12-week ONS plus silkworm pill group (30 participants, commercial ONS with mature silkworm pills) or the placebo group (32 participants, placebo ONS containing protein, carbohydrates, and fats, with placebo pills containing dextrin). During the 12-week intervention, participants consumed the allocated pills and ONS once daily. Additionally, nutritional education related to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet therapy and proper eating habits was provided at weeks 0, 3, 6, and 9. The primary outcome was interval change in the Korean version of the Repeatable Battery for the Assessment of Neuropsychological Status (K-RBANS) after the 12-week intervention. Secondary outcomes included interval changes in nutrient intake, nutrition-related blood test results, nutritional quotient, and MIND score evaluation. Results: After 12 weeks, the interval change in the delayed memory domain score of the K-RBANS was improved in the ONS plus silkworm pill group (65.9±19.0 vs. 70.5±19.0, p=0.011), and there was also a difference between the intervention and control groups (p=0.018). The interval changes in the total scale and other cognitive domain scores of the K-RBANS were not statistically significant. There were no significant differences in the pre-and post-comparison results between the placebo and ONS plus silkworm pill groups in terms of other secondary outcomes, including nutrition-related blood test results, nutritional quotient, and MIND score. Conclusion: After the 12-week intervention, the ONS and silkworm pill group showed a significant improvement in delayed memory compared with the placebo group. However, no significant differences were observed in other cognitive domains or secondary outcomes, such as nutrient intake, blood test results, nutrition quotient, or MIND score adherence. These findings suggest that, while the combination may have a positive impact on specific cognitive functions, further research is needed to fully understand its potential benefits and mechanisms of action. Clinical trial Registration: https://trialsearch.who.int/Trial2.aspx?TrialID=KCT0007304
Keywords: Mild Cognitive Impairment, silkworm, Nutritional supplements, Memory, Delayed
Received: 11 Apr 2025; Accepted: 29 Sep 2025.
Copyright: © 2025 Kim, Lee, Sun, Kim, Seo, Park, Park, Kim, Park and Moon. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yoo Park, ypark@khu.ac.kr
So Young Moon, symoon.bv@gmail.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.