UMIN ID: UMIN000056868
Registered date:30/01/2025
Exploratory Study on the Effects of Food Ingredient Intake on Daily Physical Complaints -Placebo-Controlled, Double Blind Crossover Study-
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Not applicable |
Date of first enrollment | 2025/01/31 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | After consuming the test food once, a washout period will follow, and the control food will be consumed once. After consuming the control food once, a washout period will follow, and the test food will be consumed once. |
Outcome(s)
Primary Outcome | Questionnaire on daily physical complaints |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 30years-old |
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Age maximum | 64years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1) Subjects who regularly consume pharmaceuticals or quasi-drugs that may affect the efficacy evaluation of the test food (2) Subjects who continuously consume food for specified health use, functional foods, or health foods that may affect the efficacy evaluation of the test food (3) Subjects whose lifestyle is scheduled to change drastically before or after the start of the study (including business trip, travel, etc. that will significantly change the rhythm of their daily life) (4) Subjects who are currently participating in other studies, who have participated in other studies within 4 weeks after their completion, or who are planning to participate in other studies during the study period (except for the specific studies). (5) Other subjects who are judged by the investigator as unsuitable for the study |
Related Information
Primary Sponsor | Apoplus Station Co.,Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Kanamori Giken Co., Ltd. |
Secondary ID(s) |
Contact
public contact | |
Name | Ryoko Koizumi |
Address | 2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, JAPAN Japan 103-0027 |
Telephone | 03-6777-7789 |
food-contact@apoplus.co.jp | |
Affiliation | Apoplus Station Co., Ltd. CRO Department Clinical Operations Division |
scientific contact | |
Name | Tadashi Watanabe |
Address | 1-5-16, Haneda, Ota-ku, Tokyo, 144-0043, JAPAN Japan |
Telephone | 03-3741-0223 |
wnb.cto@gmail.com | |
Affiliation | Watanabe Hospital Surgery |