UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034277 |
|---|---|
| Receipt number | R000038981 |
| Scientific Title | The effect of the algal food intake on elderly volunteers a randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2019/09/19 |
| Last modified on | 2020/06/12 11:21:43 |
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Basic information
Public title
The effect of the algal food intake on elderly volunteers
a randomized, double-blind, placebo-controlled, parallel-group study
Acronym
The effect of the algal food intake on elderly volunteers
Scientific Title
The effect of the algal food intake on elderly volunteers
a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
The effect of the algal food intake on elderly volunteers
Region
| Japan |
Condition
Condition
Healthy elderly people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the algal food intake on testosterone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
testosterone
Key secondary outcomes
QOL
Immune function
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
algal food
Interventions/Control_2
placebo control food
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
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healty people who are 65 or more to less than 75 years old.
(2)individual who can be ambulatory.
(3)Individuals who can answer the quetionair.
(4)Individuals who don't increase or decrease the amount of meals.
(5)Individuals who don't have irregular or disturbed life style such as night shifts.
Key exclusion criteria
(1)Individuals who has treatment or history of malignant tumor, heart failure, myocardial infarction, psychiatric disorder.
(2)Individuals who is being treated for arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, erectile dysfunction, thyroid disorder.
(3)Individuals who is diagnosed as menopausal disorder and not treated.
(4)Individuals who are prone to allergies for foods.
(5)Individuals who have participated in other clinical studies within the past 3 months.
(6)Individuals who intake algal food.
(7)Individuals judged inappropriate for the study by the principal.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Takahashi |
Organization
KOBELCO ECO-SOULUTIONS CO.,LTD
Division name
Technical Develop Center
Zip code
651-2241
Address
1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL
078-992-6957
md.takahashi@kobelco-eco.co.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Takahashi |
Organization
KOBELCO ECO-SOULUTIONS CO.,LTD
Division name
Technical Develop Center
Zip code
651-2241
Address
1-1-4, Murotani, Nishi-ku, Kobe 651-2241, Japan
TEL
078-992-6957
Homepage URL
md.takahashi@kobelco-eco.co.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka hospital
Institute
Department
Personal name
Funding Source
Organization
KOBELCO ECO-SOULUTIONS 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
Medical Corporation Hokubukai Utsukushigaoka hospital
Address
61-1, Shinei, Kiyota-ku, Sapporo 651-2241, Japan
Tel
011-882-0111
wakimoto@ughp-cpc.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
| 2019 | Year | 09 | Month | 19 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038981
