Unique ID issued by UMIN | UMIN000031023 |
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Receipt number | R000035427 |
Scientific Title | Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study |
Date of disclosure of the study information | 2019/01/01 |
Last modified on | 2023/08/01 09:05:50 |
Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study
Effects of Lactic acid bacteria R037 on
triglyceride elevation after high fat loading
Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study
Effects of Lactic acid bacteria R037 on
triglyceride elevation after high fat loading
Japan |
None
Not applicable | Adult |
Others
NO
To evaluate the effects of lactic acid bacteria R037 on triglyceride level after high fat loading in subjects under normal high triglyceride level
Safety,Efficacy
Efficacy:
1.Area under the triglyceride level-time curve
2.Changes of triglyceride level
Safety:
1. Doctor's questions
2. Subjective/Objective symptoms
3. Adverse events/Side effects
4. Blood pressures, Heart rate
5. Clinical laboratory tests at the end of the study
Efficacy:
1.Area under the RLP-cholesterol level-time curve
2.Changes of RLP-cholesterol level
3.Total cholesterol
4.HDL-cholesterol
5.LDL-cholesterol
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Single ingestion of placebo tablets, and high fat loading
Single ingestion of active tablets containing 100 mg of lactic acid bacteria R037, and high fat loading
Single ingestion of active tablets containing 200 mg of lactic acid bacteria R037, and high fat loading
30 | years-old | <= |
65 | years-old | >= |
Male and Female
1.Healthy men and women between 30 and 65 years of age
2.Fasting triglyceride level is between 80 and 149 mg/dL
3.Subject who don't have heavy drink habit
4.Agreed the informed consent
01.Under medication
02.Who can't stop to take supplements which may affect lipid metabolism during the study
03.Who can't stop drinking two days before screening and each examination
04.Who have an allergy to test substance
05.Who have severe disease(s) including diabetes, kidney/liver disease, heart disease, or who have metabolic disease(s) including thyroid gland disease, adrenal disease or who is under medical treatment
06.Who have chronic disease and is under medication
07.Who have digestive disease or surgery history of digestive organ(s) affecting digestion and absorption of foods
08.Inadequate subject judged by screening
09.Judged anemia by screening and cannot tolerate frequent blood sampling
10.Who has diarrhea within 1 week from date of screening
11.Blood drawing over 200 mL within 1 month or over 400 mL within 3 months from date of informed consent
12.Familial hyperlipidemia
13.Drug addict and alcohol addict
14.Who is attending another study using different food supplement(s), pharmaceutical(s), and cosmetic(s). Or who will attend another study
15.Under pregnant, or nursing, willing to become pregnant during the study
16.Person who is inappropriate for the study judged by medical doctor
24
1st name | Yoshitaka |
Middle name | |
Last name | Iwama |
Nihonbashi Cardiology Clinic
Director
103-0001
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
yiwama@well-sleep.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
Kaneka corporation
Profit organization
KOBUNA ORTHOPEDIC SURGERY
311-2, Gokan-machi, Maebashi, Gunma
027-261-7600
info@kobunaseikei.jp
NO
2019 | Year | 01 | Month | 01 | Day |
Under preparation
Unpublished
Under preparation
24
Under preparation
2020 | Year | 01 | Month | 30 | Day |
Under preparation
Under preparation
Under preparation
Under preparation
Preinitiation
2017 | Year | 12 | Month | 20 | Day |
2018 | Year | 01 | Month | 11 | Day |
2018 | Year | 01 | Month | 29 | Day |
2018 | Year | 07 | Month | 03 | Day |
2018 | Year | 01 | Month | 26 | Day |
2023 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035427
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