Health Science Research Unit, Division of Research and Development, Meiji Co., Ltd., Tokyo 192-0919, Japan.
Wellness Science Labs, Meiji Holdings Co., Ltd., Tokyo 192-0919, Japan.
Nutrients. 2024 Sep 20;16(18):3188. doi: 10.3390/nu16183188.
We investigated the effects of OLL2716 on gastrointestinal symptoms in healthy adults with gastric complaints. In this randomized, double-blind, placebo-controlled trial, 174 healthy Japanese adults were randomly assigned to an OLL2716 or placebo group, and each group consumed 85 g of yogurt containing OLL2716 or placebo yogurt daily for 12 weeks. The primary endpoint was the change in gastric symptoms from baseline as per the participants' questionnaires at 6 and 12 weeks. The secondary endpoints were changes from baseline in the short-form Nepean Dyspepsia Index (SF-NDI), the Gastrointestinal Symptom Rating Scale (GSRS), and the Council on Nutrition Appetite Questionnaire-Japanese (CNAQ-J) scores at 6 and 12 weeks. The primary endpoint data showed that the changes in "epigastric pain" at 6 and 12 weeks were significantly decreased in the OLL2716 group compared with those in the placebo group. Additionally, the changes in "epigastric pain syndrome-like symptoms" were significantly decreased in the OLL2716 group compared with those in the placebo group at 6 weeks. The SF-NDI items that improved at 6 weeks were "irritable, tense, or frustrated", "enjoyment of eating or drinking", and "tension", which are sub-scales related to mental stress. The items "Over-all" in the GSRS and "feeling hungry" in the CNAQ-J significantly improved in the OLL2716 group compared with the placebo group at 12 weeks. The results suggest that regular intake of OLL2716 may improve both gastric discomfort and mental stress in healthy adults with gastric complaints, such as postprandial fullness or early satiety.
我们研究了 OLL2716 对有胃部不适的健康成年人胃肠道症状的影响。在这项随机、双盲、安慰剂对照试验中,174 名健康的日本成年人被随机分配到 OLL2716 组或安慰剂组,每组每天食用 85 克含有 OLL2716 或安慰剂酸奶,持续 12 周。主要终点是根据参与者在 6 周和 12 周时的问卷评估从基线开始的胃部症状变化。次要终点是 6 周和 12 周时短表单 Nepean 消化不良指数(SF-NDI)、胃肠道症状评定量表(GSRS)和营养食欲问卷-日本(CNAQ-J)评分的变化。主要终点数据显示,与安慰剂组相比,OLL2716 组在 6 周和 12 周时“上腹痛”的变化明显减少。此外,OLL2716 组在 6 周时“类似上腹痛综合征的症状”的变化也明显低于安慰剂组。SF-NDI 在 6 周时改善的项目为“易怒、紧张或沮丧”、“享受进食或饮水”和“紧张”,这些是与精神压力相关的子量表。GSRS 的“整体”项目和 CNAQ-J 的“感到饥饿”项目在 12 周时在 OLL2716 组中明显优于安慰剂组。结果表明,规律摄入 OLL2716 可能改善有胃部不适的健康成年人的胃部不适和精神压力,例如餐后饱胀或早饱。
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