UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045063 |
|---|---|
| Receipt number | R000051480 |
| Scientific Title | Safety evaluation of an excessive consumption for 4 weeks of yogurt containing heat-treated lactic acid bacteria: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2024/11/15 17:13:56 |
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Basic information
Public title
Safety evaluation of an excessive consumption of test food: a randomized, double-blind, placebo-controlled trial
Acronym
Safety evaluation of test food
Scientific Title
Safety evaluation of an excessive consumption for 4 weeks of yogurt containing heat-treated lactic acid bacteria: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Safety evaluation of an excessive consumption of yogurt
Region
| Japan |
Condition
Condition
Hyperglycemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Hematologic test, blood biochemistry test, urine analysis, blood pressure/pulsation, weight/body mass index, doctor's questions, and adverse event (Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion period)
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control food (placebo): Ingestion of 3 folds dose of recommended daily intake for test food, for 4 weeks.
Interventions/Control_2
Test food: Ingestion of 3 folds dose of recommended daily intake for test food, for 4 weeks.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects giving written informed consent
2. Healthy men and women of 20 to 64 years age
3. Fasted blood glucose levels were 125 mg/dL or less and blood HbA1c levels were 6.4% or less at the screening period
Key exclusion criteria
1. Subjects with milk allergy or lactose intolerance
2. Subjects who were diagnosed with diabetes by the screening test
3. Sever systemic diseases affecting the results of this study
4. Subjects who have chronic illness and who take medication everyday
5. Subjects who were judged unsuitable as subjects by clinical examination at the screening test
6. Subjects who donated blood of more than 200 mL within a month or more than 400 mL within 3 months
7. Subjects who drink a lot of alcohol
8. Subjects who have been drug dependency
9. Subjects who participated in other clinical trials within one month before the agreement of participants in this study
10. Subjects in pregnancy or in nursing
11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL
81-27-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
81-3-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
81-27-212-5608
sagawa@mc-connect.co.jp
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
医療法人 前橋北病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
30
Results
A randomized, placebo-controlled, double-blind, parallel-group comparative study was conducted to investigate the safety of consuming three servings of yogurt containing Lactiplantibacillus plantarum OLL2712 (OLL2712) per day, and the results showed that there were no safety issues with excessive consumption of OLL2712.
Results date posted
| 2024 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty healthy adults aged from 20 to 64 years old with fasting blood glucose levels of 125 mg per dL or less and HbA1c levels of 6.4% or less were randomly assigned into two groups.
Participant flow
All participants completed this study without exhibiting any problematic findings in the interview or subjective symptoms.
Adverse events
There were no clinically concerning changes in blood or urine tests or adverse events related to the test yogurt containing L. plantarum OLL2712 in this study.
Outcome measures
As a physical examination, height, weight, systolic blood pressure, diastolic blood pressure, and pulse rate were measured.
As a hematological examination, white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, MCV, MCH, MCHC, and white blood cell count were measured.
As part of the blood biochemistry tests, AST, ALT, LDH, total bilirubin, ALP, GTP, blood glucose, HbA1c, insulin, total cholesterol, LDL cholesterol, HDL cholesterol sterol, triglycerides, total protein, albumin, urea nitrogen, creatinine, uric acid, sodium, chloride, potassium, calcium, inorganic phosphorus, magnesium, and serum iron.
As a urine test, the pH and specific gravity were measured. As part of the urine test (qualitative), we evaluated urine protein, urine sugar, urobilinogen, bilirubin, ketone bodies in urine, and occult blood reactions.
A medical interview was conducted to investigate subjective symptoms and objective findings that occurred during the study period, the status of the test food intake, and changes in lifestyle and diet.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 06 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051480
