UMIN-CTR Clinical Trial

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

hyperlipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Soiken Inc.

Institute

Department

Personal name

Organization

Megmilk Snow Brand Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

08

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

08

Month

30

Day

Last modified on

2013

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010773