UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011605
Receipt No. R000010773
Scientific Title A clinical trial of the effect of yogurt containing Lactobacillus gasseri (LG2055) on postprandial triglyceride, nonesterified fatty acids and glucose metabolism
Date of disclosure of the study information 2013/08/30
Last modified on 2013/08/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical trial of the effect of yogurt containing Lactobacillus gasseri (LG2055) on postprandial triglyceride, nonesterified fatty acids and glucose metabolism
Acronym A clinical trial of the effect of Lactobacillus gasseri (LG2055) on postprandial triglyceride and nonesterified fatty acids metabolism
Scientific Title A clinical trial of the effect of yogurt containing Lactobacillus gasseri (LG2055) on postprandial triglyceride, nonesterified fatty acids and glucose metabolism
Scientific Title:Acronym A clinical trial of the effect of Lactobacillus gasseri (LG2055) on postprandial triglyceride and nonesterified fatty acids metabolism
Region
Japan

Condition
Condition hyperlipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of yogurt containing Lactobacillus gasseri (LG2055) on postprandial hyperlipidemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Serum triglyceride and nonesterified fatty acid levels in lipid and glucose absorption test after 4-week intake
Key secondary outcomes Blood glucose level in lipid and glucose absorption test after 4-week intake

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 200g/day for 4 weeks
twice a day, 100g each after breakfast and dinner

intake of placebo yogurt for 4 weeks -> washout period for 4 weeks -> intake of yogurt containing Lactobacillus gassreri (LG2055) for 4 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)TypeIIb or typeIV hyperlipoproteinemia in NCEP ATPIII(fasting serum triglyceride level >=200 mg/dL)
2)Normal blood glucose level(fasting blood glucose level<110 mg/dL)
3)Nonsmoker
4)Subject, upon briefing of the content of the present study, fully understands and agrees to its objective and is able to personally give written informed consent
Key exclusion criteria 1)Subject having treatment or previous history for serious cardiovascular, respiratory, endocrine, or metabolic disorders
2)Subject having coronary heart disease, renal disorder, hypothyroidism, liver disorder
3)Subject taking medicine for promoting excretion from stomach, lipoprotein metabolism, insulin secretion and insuline activation
4)Subject being on a diet therapy
5)Subject taking FOSHU for decreasing serum triglyceride level, body fat or blood glucose level
6)Subject who ended participation in another clinical trial less than 3 months before and who is currently involved in another clinical trial
7)Subject having a food allergy, especially dairy products
8)For female subjects: pregnancy or possibility of pregnancy, or intending to become pregnant during the study.
9) Subject who has had a blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study.
10) Subject deemed unsuitable by the investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kajimoto Osami
Organization Osaka City University Graduate School of Medicine
Division name Department of Medical Science on Fatigue
Zip code
Address 1-4-3 Asahi-machi Abeno-ku, Osaka
TEL 06-6645-2637
Email kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sugino Tomohiro
Organization Soiken Inc.
Division name R&D division
Zip code
Address Senri Life Science Center 13F, 1-4-2 Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization Megmilk Snow Brand Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 30 Day
Last modified on
2013 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.