Unique ID issued by UMIN | UMIN000054009 |
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Receipt number | R000061645 |
Scientific Title | Investigation on the anti-obesity effects of research food intake |
Date of disclosure of the study information | 2024/03/29 |
Last modified on | 2024/03/29 16:07:35 |
Investigation on the anti-obesity effects of research food intake
Investigation on the anti-obesity effects of research food intake
Investigation on the anti-obesity effects of research food intake
Investigation on the anti-obesity effects of research food intake
Japan |
Healthy adult male/female
Adult |
Others
NO
Investigate the anti-obesity effects of research food on Japanese subjects
Safety,Efficacy
Abdominal fat area
1. Gut microbiota
2. Gut metabolomes
3. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor of defecation)
4. Abdominal symptoms (bloating, belching, gas) at times other than during defecation
5. Body weight, BMI, waist circumference, body composition
6. OSA-MA
7. POMS2 short version
8. GLP-1, PYY
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Consume 16 g/day of research food for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
(2) 25=<BMI<30 kg/m^2 at informed consent.
(3) Average number of steps per day is less than 10,000 steps.
(4) No metal (pacemaker, etc.) in their body and are able to take CT scan.
(5) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.
(1) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods (including supplements) that may affect the research (anti-obesity, lipid metabolism, appetite control, intestinal regulation, etc.) from the time consent is obtained.
(2) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test.
(3) Subjects who plan to take drugs that will affect the research during the study.
(4) Subjects with a history of appendectomy.
(5) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent.
(6) Subjects undergoing dietary restriction or weight loss.
(7) Subjects who plan to lose weight during the study.
(8) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study.
(9) Subjects with extremely irregular eating habits.
(10) Subjects with special dietary habits (vegetarian, vegan, low-carbo).
(11) Subjects whose roommates plan to participate in the study.
(12) Smokers.
(13) Heavy alcohol drinkers.
(14) Subjects with previously diagnosed diabetes mellitus (type 1/type 2) or dyslipidemia.
(15) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(16) Pregnant, lactating, or intending to become pregnant during the study.
(17) Subjects allergic to medicines and foods.
(18) Subjects who are aware of excessive abdominal symptoms (severe diarrhea or bloating) when ingesting oligosaccharides.
(Due to character limitation, the following will be listed in the "Others" section)
20
1st name | Shinnosuke |
Middle name | |
Last name | Murakami |
Metagen, Inc.
Headquarters
997-0052
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata 997-0052, Japan
+81-235-64-0330
research@metagen.co.jp
1st name | Fumiko |
Middle name | |
Last name | Nakamura |
CPCC Company Limited
Clinical Support Division
103-0021
4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
+81-3-6225-9001
cpcc-contact@cpcc.co.jp
Metagen, Inc.
Meiji Food Materia Co., LTD.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
+81-3-6225-9005
IRB@cpcc.co.jp
NO
2024 | Year | 03 | Month | 29 | Day |
Unpublished
Preinitiation
2024 | Year | 03 | Month | 18 | Day |
2024 | Year | 04 | Month | 01 | Day |
2024 | Year | 08 | Month | 04 | Day |
(Continuing from exclusion criteria)
(19) Participating in a clinical study of another drug or health food, within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study.
(20) Subjects who have donated 200 mL of blood in one month before start of the study.
(21) Males who have donated 400 mL of blood within 3 months before start of the study.
(22) Females who have donated 400 mL of blood within 4 months before start of the study.
(23) Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL.
(24) Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL.
(25) Those who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.
2024 | Year | 03 | Month | 29 | Day |
2024 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061645
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