Unique ID issued by UMIN | UMIN000028005 |
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Receipt number | R000032069 |
Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Reducing Body Fat by Daily Ingestion of Sea Urchin's Gonads |
Date of disclosure of the study information | 2017/06/29 |
Last modified on | 2019/02/28 14:24:40 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Reducing Body Fat by Daily Ingestion of Sea Urchin's Gonads
Effects of Reducing Body Fat by Daily Ingestion of Sea Urchin's Gonads
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Reducing Body Fat by Daily Ingestion of Sea Urchin's Gonads
Effects of Reducing Body Fat by Daily Ingestion of Sea Urchin's Gonads
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the overall effects of 12-week daily ingestion of supplements made from sea urchin's gonads for reducing body fat and also for anti-inflammatory and intestinal regulatory effects as the secondary outcomes.
Efficacy
Pragmatic
Not applicable
Abdominal visceral fat area after 6 and 12 weeks of ingestion
Abdominal total fat area, abdominal subcutaneous fat area, body weight, BFP, BMI, waist circumference, hip circumference, waist-hip ratio, BP measured at the hospital, TC, LDL-C, HDL-C, TG, fasting blood glucose levels, HbA1c, adiponectin, leptin and VAS questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
Daily ingestion of 16 tablets (3.2g freeze dried sea urchin's gonads/day) for 12 weeks.
Daily ingestion of 16 placebo tablets for 12 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Subjects whose BMI is>=23 kg/m2 and <30 kg/m2.
2. Subjects who agree to participate in this study with a written informed consent.
1. Subjects who are under physician's advice, treatment and/or medication for obese, hyperlipidemia and diabetes.
2. Subjects whose BMI is >=30 kg/m2.
3. Subjects with familial hypercholesterolemia.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects who use pacemaker or defibrillator.
6. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
8. Subjects with severe anemia.
9. Pre- or post-menopausal women complaining obvious physical changes.
10. Subjects who are at risk of having allergic reactions to drugs or foods based on especially sea urchin and salmon roe.
11. Subjects who regularly take drugs, functional foods, and/or supplements which would affect BW and BFP.
12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels.
13. Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism.
14. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle.
15. Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study.
16. Pregnant or lactating women or women expect to be pregnant during this study.
17. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
18. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
40
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Ministry of Agriculture, Forestry and Fisheries, Government of Japan
Japanese Governmental office
Japan
Graduate School of Fisheries Sciences, National University Corporation Hokkaido University
NO
北海道情報大学 保健センター(北海道)
2017 | Year | 06 | Month | 29 | Day |
Unpublished
Completed
2017 | Year | 05 | Month | 29 | Day |
2017 | Year | 07 | Month | 12 | Day |
2017 | Year | 11 | Month | 11 | Day |
2017 | Year | 11 | Month | 28 | Day |
2017 | Year | 12 | Month | 05 | Day |
2018 | Year | 04 | Month | 13 | Day |
2017 | Year | 06 | Month | 29 | Day |
2019 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032069
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