Unique ID issued by UMIN | UMIN000038725 |
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Receipt number | R000044131 |
Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation. |
Date of disclosure of the study information | 2019/12/02 |
Last modified on | 2021/04/09 17:39:19 |
A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.
Study on the effect of food containing fucose on obesity and constipation.
A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.
Study on the effect of food containing fucose on obesity and constipation.
Japan |
Healthy and overweight adult subjects between 23 or more and less than 30 in body mass index (BMI)
Not applicable |
Others
NO
To examine the effect of food containing fucose on obesity and constipation.
Efficacy
Confirmatory
Not applicable
Visceral fat area
*Assess the fat area by X-ray CT
1. Subcutaneous fat area
2. Total fat area
3. Visceral fat area
4. Subcutaneous fat area
5. Total fat area
6. Waist and Hip circumference
7. Body weight
8. Defecation frequency
9. Bristol stool scale
*1-2 Assess these by X-ray CT
*3-5 Assess these by Bioelectrical impedance analysis
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Numbered container method
2
Treatment
Food |
Ingestion of supplement containing fucose for 20 weeks.
Ingestion of placebo without fucose for 20 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Healthy males and females aged 20 to 64 years old
2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI
3. Subjects with subjective symptoms of chronic constipation
4. Subjects who can make self-judgment and are voluntarily giving written informed consent
1. Subjects who use medications affecting obesity and constipation
2. Subjects who cannot stop using supplements and/or functional foods affecting obesity and constipation
3. Subjects who are under treatment or have a history of disease e.g., serious liver disease, heart disease, respiratory insufficiency, endocrine disorder, metabolic diseases or food allergy
4. Subjects who have under treatment or a history of drug addiction and/or alcoholism
5. Subjects who have implanted metal in the abdominal area, as detected by computerized tomography
6. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
7. Subjects who have been diagnosed as familial hyperlipidemia
8. Subjects who has food allergy
9. Subjects who are participating or planning to participate in other clinical studies to examine effects of food, medicine or cosmetics
10. Subjects who are planning to become pregnant during the study or are pregnant or lactating
11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
80
1st name | Satoru |
Middle name | |
Last name | Suzuki |
Shinagawa Season Terrace Health Care Clinic
General Manager of Medical Examination Department
108-0075
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
03-3452-3381
satoru_suzuki@sempos.or.jp
1st name | Eiji |
Middle name | |
Last name | Yoshikawa |
KSO Corporation
Sales department
105-0023
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
Japan Science and Technology Agency
Japanese Governmental office
Yaizu Suisankagaku Industry Co., Ltd.
Shinagawa Season Terrace Health Care Clinic
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
03-3452-3381
tomohiro_kogo@sempos.or.jp
NO
2019 | Year | 12 | Month | 02 | Day |
Unpublished
Completed
2019 | Year | 11 | Month | 20 | Day |
2019 | Year | 12 | Month | 14 | Day |
2020 | Year | 01 | Month | 06 | Day |
2020 | Year | 07 | Month | 31 | Day |
2019 | Year | 11 | Month | 29 | Day |
2021 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044131
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