UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027709 |
|---|---|
| Receipt number | R000031741 |
| Scientific Title | Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2024/11/17 20:14:06 |
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Basic information
Public title
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Acronym
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria
Scientific Title
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria
Region
| Japan |
Condition
Condition
Overweight
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of reducing body fat by the intake of food containing lactic acid bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Abdominal total fat area
Abdominal visceral fat area
Abdominal subcutaneous fat area
Key secondary outcomes
Body weight
Body mass index
Body fat percentage
Waist circumference, Hip circumference, Waist circumference/hip circumference
Blood fat level (triglyceride, total cholesterol, HDL cholesterol, LDL cholesterol)
Blood glucose level
HbA1c
Insulin
HOMA-IR
Blood ketone bodies level
Blood inflammatory cytokines
Blood adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week intake of the test food
Interventions/Control_2
12-week intake of the placebo food
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)Healthy men and women of 20 to 64 years age
2)Subjects whose body mass indexes were 25 to 30 at the screening period
3)Subjects giving written informed consent
Key exclusion criteria
1)Subjects with severe onset of obesity-related disease (impaired glucose tolerance, dyslipidemia, hypertension, hyperuricemia, coronary artery disease, cerebral infarction, fatty liver, menstrual disorder and pregnancy complications, sleep apnea syndrome or obesity hypoventilation syndrome, orthopedic surgery, obesity-related kidney disease)
2)Subjects with food allergy or lactose intolerance
3)Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in three months before screening test
4)Subjects with a habit of oral medication, supplements, health food affecting obesity, hyperlipidemia, glucese or lipid matabolism in three months before screening test, and subjects who will take these in the test period.
5)Subjects who are regularly practicing intense exercise (exercising for the purpose of muscle strengthening, attending exercise facilities more than three times in a week, etc.)
6)Subjects who have been drug dependency or alcohol dependency
7)Subjects who drink a lot of alcohol, and subjects who can not abstain from drinking from two days before the examination date
8)Subjects who have metal in the measurement site of CT scan
9)Subjects who contain cardiac pacemaker, implantable defibrillator
10)Subjects who have been diagnosed with familial hyperlipemia
11)Subjects in pregnancy or in nursing
12)Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker)
13)Subjects who participated in other clinical trials within one month before the agreement of participants in this study
14)Subjects with claustrophobia
15)Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Medical examination and treatment management family chief director
Zip code
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
81-3-3452-3381
satoru_suzuki@sempos.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka buildin
TEL
81-3-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Food Microbiology Research Laboratories, Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://cdn.nutrition.org/article/S2475-2991(22)10516-0/fulltext
Publication of results
Published
Result
URL related to results and publications
https://cdn.nutrition.org/article/S2475-2991(22)10516-0/fulltext
Number of participants that the trial has enrolled
100
Results
The 12 week change of abdominal fat area and fasting plasma glucose were significantly less in the OLL2712 group than the placebo group. The overall trend of serum IL-6 was significantly decreased in the OLL2712 group compared with baseline and the placebo group.
Results date posted
| 2024 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study participants included 100 overweight (BMI range, 25 to 30 kg per m2) adults aged from 20 to 64 y.
Participant flow
352 candidates were screened and provided written informed consent for study participation. Of these, 108 were ineligible for study inclusion after not meeting the inclusion criteria or due to the exclusion criteria, 8 declined to participate, and 136 were excluded for other reasons. A total of 100 individuals without any disease or a diagnosis of obesity by the principal investigator were selected in order based on proximity to an abdominal visceral fat area of 100 cm2 and were assigned randomly to the OLL2712 group (n = 50) or the placebo group (n = 50).
Adverse events
No serious adverse events were reported in the study, although a total of 29 nonserious adverse events were documented in the participants diaries, medical interviews, and blood tests. There were no significant differences in the incidence of adverse events between the groups, and none of these were judged to be associated with the consumption of the test yogurt by the lead physician. The physician determined that the changes in all parameters of the blood and urine tests were within normal limits.
Outcome measures
The primary outcome measures were change in the abdominal fat areas by 12 wk. The secondary outcomes were changes in body weight, BMI, body fat percentage, waist-to-hip circumference, and metabolic risk factors such as glycemic control, lipid profiles, and chronic inflammation markers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2024 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031741
