UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057293 |
|---|---|
| Receipt number | R000065491 |
| Scientific Title | The impact of lifestyle interventions on health outcomes: a pilot study |
| Date of disclosure of the study information | 2025/04/26 |
| Last modified on | 2025/05/02 12:41:31 |
* 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
The impact of lifestyle interventions on health outcomes: a pilot study
Acronym
The impact of lifestyle interventions on health outcomes: a pilot study
Scientific Title
The impact of lifestyle interventions on health outcomes: a pilot study
Scientific Title:Acronym
The impact of lifestyle interventions on health outcomes: a pilot study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of multi-factorial lifestyle interventions with dairy product on health outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight, Health outcomes (blood, stool, questionnaires)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food (dairy product) and lifestyle interventions for 12 weeks
Interventions/Control_2
Non-intervention
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1) Men aged 50 to 74 years.
2) Individuals who can understand the purpose and content of this study, and voluntarily wish to participate, and have provided written consent for participation in this study.
3) Individuals with a Body Mass Index of 25 or higher.
4) Individuals who do not have a habit of consuming fermented milk (up to once a week).
5) Individuals who can measure their daily step count regularly.
6) Individuals who are able to exercise regularly (those who have not been advised against exercise by a doctor).
Key exclusion criteria
1) Individuals who have or have a history of severe diseases such as malignant tumors, gastrointestinal, and metabolic disorders.
2) Individuals who have or have a history of intestinal diseases.
3) Individuals who have or have a history of drug or food allergies.
4) Individuals who have lactose intolerance.
5) Individuals who regularly use medications including laxatives, digestive aids, or stool softeners.
6) Individuals who have taken antibiotics for more than a week within the past three months.
7) Individuals who cannot discontinue the use of Food for Specified Health Uses (FOSHU), Foods with Functional Claims, Food with Nutrient Function Claims, or beverages/foods containing bifidobacteria, lactic acid bacteria, oligosaccharides, lactoferrin, etc., during the study period.
8) Individuals who are on a diet or losing weight through exercise.
9) Individuals who have a habit of skipping meals.
10) Individuals who are under medical supervision for exercise guidance, dietary therapy, or health direction.
11) Individuals who engage in moderate to high-intensity exercise for more than 30 minutes, at least three times a week.
12) Heavy smokers (those who smoke an average of 21 or more cigarettes per day).
13) Individuals whose daily alcohol consumption exceeds an average of 60 grams of pure alcohol per day.
14) Individuals who have donated or had blood drawn exceeding 200 mL within one month or 400 mL within three months before the screening test.
15) Individuals who work night shifts, have irregular weekly rotating shifts, engage in physical labor, or have irregular lifestyle habits.
16) Individuals who may change their lifestyle habits during the study period.
17) Individuals who have participated in other drug or food trials in the past month or intend to participate in such trials.
18) Individuals who are deemed unsuitable as subjects by the principal investigator based on their background, physical examination, physical tests, and clinical examination results.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anera Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.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
Morinaga Milk Industry 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, Gunma
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
医療法人財団健康睡眠会 日本橋循環器科クリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 26 | 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
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065491
