UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052152 |
|---|---|
| Receipt number | R000059516 |
| Scientific Title | A study investigating the effect of dairy products in obese subjects: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2023/09/08 |
| Last modified on | 2023/09/08 12:36:38 |
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Basic information
Public title
A study investigating the effect of dairy products in obese subjects: A randomized, double-blind, placebo-controlled, parallel-group study
Acronym
A study investigating the effect of dairy products in obese subjects
Scientific Title
A study investigating the effect of dairy products in obese subjects: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
A study investigating the effect of dairy products in obese subjects
Region
| Japan |
Condition
Condition
Obese adult males with abnormalities in glucose metabolism, lipid metabolism, or blood pressure
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is investigating the effects of combined use of dairy products and oligosaccharides on glucose metabolism, lipid metabolism, and blood pressure in obese subjects. In addition, the characteristics of the subjects in whom efficacy will occur and the appropriate endpoints will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Fasing blood glucose
Glycoalbumin
Non-HDL-cholesterol
Blood pressure
In addition to the overall analysis, subgroup analysis will also be performed by dividing subjects according to the presence or absence of abnormal values for each endpoint.
Key secondary outcomes
HbAlc (NGSP)
Serum insulin
homeostatis model assesment-insulin resistance (HOMA-IR)
Serum triglyceride
Serum total cholesterol
Serum LDL-cholesterol
Serum HDL-cholesterol
Plasma incretin levels
Plasma cytokine kevels
Fecal microbiota
Factors related to intestinal environment
body fat percentage
waist circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of fermented dairy products containing lactic acid bacteria and oligosaccharide syrup for 8 weeks
Interventions/Control_2
Ingestion of placebo milk and placebo syrup for 8 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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Subjects who meet the following criteria in the screening test
1. Age between 20 and 64 years old
2. BMI between 25 and 30
3. One or more of following applies
(1) Fasting blood glucose between 100 and 125 mg/dL
(2) Non-HDL-cholesterol concentration between 150 and 189 mg/dL
(3) Systolic blood pressure between 130 and 159 mmHg and/or diastolic blood pressure between 85 and 99 mmHg
Key exclusion criteria
1. Those taking hypoglycemic agents, lipid-lowering agents, or antihypertensive agents.
2. Those who take functional foods or supplements that affect glucose and lipid metabolism and blood pressure on a daily basis.
3. Those who are suffering from or have a history of serious heart, liver, kidney, or digestive organ diseases.
4. Those who have an implantable medical device such as a cardiac pacemaker or an implantable cardioverter-defibrillator.
5. Subjects with allergies to milk or soybeans.
6. Those who are judged to be unsuitable as subjects based on the results of the medical interview and the contents of the questionnaire, etc.
7. Persons who routinely consume foods containing lactobacilli or bifidobacteria, foods containing non-digestible oligosaccharides, and beverages, or consume a large amount of such foods and beverages.
8. Subjects who are taking antibiotics on a daily basis.
9. Those hose who are judged to be unsuitable as subjects by the investigator's judgment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsuge |
| Middle name | |
| Last name | Daisuke |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
Shinagawa Season Terrace 5F, 1-2-70 Konan, Minato-ku, Tokyo
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management Department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
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
品川シーズンテラス健診クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059516
