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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033063
Receipt No. 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 2019/06/25

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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
Email 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
Email maznahis@upm.edu.my

Sponsor
Institute Institute of Bioscience, Universiti Putra Malaysia
Institute
Department

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
Email 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
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
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.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


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