Unique ID issued by UMIN | UMIN000050393 |
---|---|
Receipt number | R000057374 |
Scientific Title | Effects of consumption of the test food on the intestinal environment and blood lipid in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/12/01 |
Last modified on | 2024/03/14 11:35:31 |
Effects of consumption of the test food on the intestinal environment and blood lipid in healthy Japanese subjects
Effects of consumption of the test food on the intestinal environment and blood lipid in healthy Japanese subjects
Effects of consumption of the test food on the intestinal environment and blood lipid in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on the intestinal environment and blood lipid in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on the intestinal environment and blood lipid in healthy Japanese subjects
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The defecation frequency
1. The numbers of defecation days, amount of defecation, stool shape, stool smell, and exhilarating feeling of defecation
2. The quantitative value of Akkermansia muciniphila (copies/g)
3. Body weight, body mass index (BMI), body fat percentage, fat mass, lean body mass, and muscle mass
4. Total cholesterol (T-Cho), high-density lipoprotein cholesterol (HDL-Cho), low-density lipoprotein cholesterol (LDL-Cho), LDL-Cho/HDL-Cho ratio, and triglyceride (TG)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Duration: 12 weeks
Test food: Capsule containing apple polyphenol
Administration: Take four capsules with water after breakfast one daily
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Test food: Capsule not containing apple polyphenol
Administration: Take four capsules with water after breakfast one daily
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose defecation frequency is three to five times per week
6. Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products (particularly such as apple, apricot, almond, plum, peach, pear, strawberry, or birch)
7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in this study by the physician
11. Subjects who usually take food/beverage containing functional ingredients that may influence the intestinal environment (e.g. dietary fiber, indigestible dextrin, isomaltodextrin, inulin, guar gum degradation products, fructooligosaccharides, galactooligosaccharides, lactulose, lactic acid bacteria, bifidobacteria, butyric acid bacteria, Bacillus subtilis var. natto, maltobionic acid, fucose, cocoa polyphenols, raffinose, kestose, polydextrose, lactosucrose, xylooligosaccharide, isomaltooligosaccharide, psyllium, resistant starch, galactomannan, or glucomannan)
20
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
ORTHOMEDICO Inc.
Self funding
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
BGG Japan Co., Ltd.
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2023 | Year | 12 | Month | 01 | Day |
Unpublished
24
Completed
2023 | Year | 02 | Month | 15 | Day |
2023 | Year | 02 | Month | 15 | Day |
2023 | Year | 02 | Month | 27 | Day |
2023 | Year | 09 | Month | 08 | Day |
2023 | Year | 02 | Month | 21 | Day |
2024 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057374