UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056839 |
|---|---|
| Receipt number | R000064664 |
| Scientific Title | Effects of Consuming Nutritional Foods on Quality of Life and Nutrient Intake Status in Middle-Aged Women |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2026/02/03 15:49:25 |
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Basic information
Public title
Effects of Consuming Nutritional Foods on Quality of Life and Nutrient Intake Status in Middle-Aged Women
Acronym
Effects of Consuming Nutritional Foods on Quality of Life and Nutrient Intake Status in Middle-Aged Women
Scientific Title
Effects of Consuming Nutritional Foods on Quality of Life and Nutrient Intake Status in Middle-Aged Women
Scientific Title:Acronym
Effects of Consuming Nutritional Foods on Quality of Life and Nutrient Intake Status in Middle-Aged Women
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consuming nutritional foods on quality of life and nutrient intake status.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health Related Quality of Life (SF-36v2 (standard version))
Key secondary outcomes
Energy and nutrient intake
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
Intake of test foods for 12 weeks
Interventions/Control_2
No intake of test foods for 12 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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy women who are between 60 and 74 years of age at the time of the preliminary survey/inspection.
(2) BMI ranging from 17 to < 30.
(3) Persons who have been sufficiently informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and have given their consent to participate in the study in writing.
(4) Persons who are able to intake the test foods continuously from the begining to the end of the study.
Key exclusion criteria
(1) Persons who are on continuous dietary guidance, diet therapy, or medication that may affect this study for the treatment of disease, etc.
(2) Persons who suffer from or have a history of psychiatric disorders or serious gynecological disorders.
(3) Persons with severe menopausal symptoms.
(4) Persons who have an extremely irregular diet, drink excessive amounts of alcohol on a daily basis, work in shifts, or work late at night.
(5) Persons with a history or current medical history of drug dependence or alcohol dependence.
(6) Persons who are participating, intend to participate, or have participated within the past 3 months in tests of other foods, tests involving the use of drugs, or tests involving the application of cosmetics, drugs, etc.
(7) Persons who are scheduled to travel abroad or on a long business trip and cannot intake the test foods for the duration of the study.
(8) Persons who take nutritional supplements or dietary supplements on a daily basis that may affect the results of the study.
(9) Persons who are suspected to have cognitive impairment.
(10) Persons with sleep disorders.
(11) Persons with a history of drug allergy or food allergy.
(12) Persons who have reported lactose intolerance.
(13) Patients with implanted medical devices such as pacemakers.
(14) Persons with an excessive smoking habit (21 or more cigarettes per day).
(15) Persons who had more than 400 mL of blood drawn within 12 weeks prior to the start of intake, or more than 200 mL of blood drawn during the previous observation period.
(16) Any subject who is judged to be unsuitable as a subject by the investigator or subinvestigator based on the results of the subject's background, physical findings, physical examination, and clinical examination.
Target sample size
60
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
8th Floor, Anela Building, 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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | 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
60
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 22 | 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 | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064664
