UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037699