UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057978 |
|---|---|
| Receipt number | R000066284 |
| Scientific Title | Effect of Mixed Nut Snacking on Menopausal Symptoms |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/05/27 10:54:08 |
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Basic information
Public title
Effect of Mixed Nut Snacking on Menopausal Symptoms
Acronym
Effect of Mixed Nut Snacking on Menopausal Symptoms
Scientific Title
Effect of Mixed Nut Snacking on Menopausal Symptoms
Scientific Title:Acronym
Effect of Mixed Nut Snacking on Menopausal Symptoms
Region
| Japan |
Condition
Condition
menopausal disorders
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Menopause involves hormonal changes that can trigger a range of metabolic and physiological symptoms, including impaired glucose regulation, increased risk of diabetes, and vasomotor and psychological disturbances. Dietary interventions, particularly those incorporating foods rich in dietary fiber and phytoestrogens, have shown potential in alleviating these symptoms. However, previous studies using fiber-rich but carbohydrate-free snacks, such as black soybeans, reported limited second-meal effects due to the lack of carbohydrates. To address this limitation, we formulated a mixed nuts snack containing both dietary fiber and moderate carbohydrates from dried mangoes and investigated its impact on blood glucose levels, hormone levels, and menopausal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose changes associated with diet, sleep evaluation questionnaire, menopausal index questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Mixed Nuts
Interventions/Control_2
Mango
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Menopausal index of 40 or more in the preliminary questionnaire
Key exclusion criteria
Medication in Menopause
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1330057
Address
5-7-1 Nishikoiwa, Edogawa-ku, Tokyo
TEL
0356687260
furutani@aikoku-jc.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1330057
Address
5-7-1 Nishikoiwa, Edogawa-ku, Tokyo
TEL
0356687260
Homepage URL
furutani@aikoku-jc.ac.jp
Sponsor or person
Institute
Aikoku Gakuen Junior College
Institute
Department
Personal name
Funding Source
Organization
Aikoku Gakuen Junior College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aikoku Gakuen Junior College
Address
5-7-1 Nishikoiwa, Edogawa-ku, Tokyo
Tel
0356687260
furutani@aikoku-jc.ac.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 | 05 | Month | 27 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066284
