UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033063 |
|---|---|
| Receipt number | R000037699 |
| Scientific Title | Anti-aging and cardio-protective effects of edible bird's nest in perimenopause women |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2021/06/24 10:05:48 |
* 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
Anti-aging and cardio-protective effects of edible bird's nest in perimenopause women
Acronym
Anti-aging and cardio-protective effects of edible bird's nest in perimenopause women
Scientific Title
Anti-aging and cardio-protective effects of edible bird's nest in perimenopause women
Scientific Title:Acronym
Anti-aging and cardio-protective effects of edible bird's nest in perimenopause women
Region
| Asia(except Japan) |
Condition
Condition
Healthy perimenopause women
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To conduct a single blind randomized controlled trial on the anti-aging and cardio-protective properties of EBN in peri-menopause women
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical analysis (Lipid profile, liver and kidney function tests, reproductive hormones, human apolipoprotein, inflammation markers) at baseline and post-treatment.
Key secondary outcomes
Skin condition analysis, gene expression analysis, as well as physical activity, dietary pattern and anthropometric changes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Testing sample comprised of 3 grams of double boiled edible bird's nest, 1 g agar, 2 g sugar and 200 ml water. The testing sample was packed in retort pouches. The subjects are required to take the sample on a daily basis for 3 months.
Interventions/Control_2
Placebo sample comprised of 1 g agar, 2 g sugar and 200 ml water. The placebo sample was packed in retort pouches. The subjects are required to take the sample on a daily basis for 3 months.
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Perimenopause women with irregular menstruation
Key exclusion criteria
1. Pregnant
2. Having chronic metabolic or endocrine diseases
3. Taking medication for chronic diseases, using herbal medicines or supplement
4. Undergoing hormone replacement therapy (HRT) at present
5. Menopause women including surgical menopause
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Maznah |
| Middle name | |
| Last name | Ismail |
Organization
Institute of Bioscience, Universiti Putra Malaysia
Division name
Laboratory of Molecular Biomedicine
Zip code
43400
Address
Institute of Bioscience, Universiti Putra Malaysia, Serdang UPM, Selangor, Malaysia.
TEL
0389472115
maznahis@upm.edu.my
Public contact
Name of contact person
| 1st name | Maznah |
| Middle name | |
| Last name | Ismail |
Organization
Institute of Bioscience, Universiti Putra Malaysia
Division name
Laboratory of Molecular Biomedicine
Zip code
43400
Address
Institute of Bioscience, Universiti Putra Malaysia, Serdang UPM, Selangor, Malaysia.
TEL
0389472115
Homepage URL
maznahis@upm.edu.my
Sponsor or person
Institute
Institute of Bioscience, Universiti Putra Malaysia
Institute
Department
Personal name
Funding Source
Organization
Department Of Veterinary Services Malaysia, Ministry of Agriculture and Agro-Based Industry Malaysia
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
Address
Ethics Committee for Research Involving Human Subjects, Office of the Deputy Vice Chancellor (Research & Innovation), Universiti Putra Malaysia, 43400 Serdang UPM, Selangor, Malaysia.
Tel
+(60)3-9769 1002
jkeupm@upm.edu.my
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
| 2018 | Year | 06 | Month | 20 | 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
54
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Pending result analysis
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
| 2018 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037699
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
