UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Continuous Intake of Dried Olive Leaf Tea on Hematological Parameters -A Comparison Study Among Three Random Groups in Bangladesh-
Acronym	The Study of Continuous Intake of Dried Olive Leaf Tea
Scientific Title	Effects of Continuous Intake of Dried Olive Leaf Tea on Hematological Parameters -A Comparison Study Among Three Random Groups in Bangladesh-
Scientific Title:Acronym	The Study of Continuous Intake of Dried Olive Leaf Tea
Region	Asia(except Japan)

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of continuous intake of dried olive leaf tea in hematology parameters in healthy to mildly anemic young people in Bangladesh.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in hemoglobin (Hb) concentration 12 weeks after intervention
Key secondary outcomes	1) Change in Hb concentration 6 weeks after intervention 2) Change in red blood cell count (RBC) 6 and 12 weeks after intervention 3) Change in White blood cell count, hematocrit, MCV, MCH, MCHC, serum iron concentration, serum ferritin concentration, and lipid profile 6 and 12 weeks after intervention 4) Changes in score of each item of FAS questionnaire after 6 and 12 weeks of intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Placebo(12weeks)
Interventions/Control_2	Low dose dried olive leaf tea(12weeks)
Interventions/Control_3	Normal dose dried olive leaf tea(12weeks)
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	15 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who are 15 to 59 years old. 2) Those who will provide written consent to participate in this research.
Key exclusion criteria	1) If you are currently pregnant or breastfeeding or have the possibility within 4 months. 2) For those with moderate to severe anemia (hemoglobin concentration less than 10 g / dL for women and less than 11 g / dL for men). 3) Those who have any of the medical conditions, such as hematological diseases, malignant tumors, aplastic anemia, uncontrolled hypertension, chronic kidney disease, irritable bowel syndrome, and cardiovascular diseases. 4) Those who are currently taking medicine for diabetes or hypertension drugs. 5) If you currently use iron or other supplements regularly. 6) If you are participating in other clinical trials. 7) Those who may move out of the research area within 4 months. 8) Those who are considered as ineligible by the study physician.
Target sample size	165

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Isoda
Organization	University of Tsukuba
Division name	Faculty of Life and Environmental sciences
Zip code	305-8577
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	+81-029-853-7871
Email	isoda.hiroko.ga@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name Farhana Middle name Last name Ferudousi
Organization	University of Tsukuba
Division name	Research Center for Mediterranean and North African Studies
Zip code	305-8577
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	+81-029-853-7871
Homepage URL
Email	ferdousi.farhana.fn@u.tukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Name of secondary funder(s)	Japan Science and Technology Agency (JST) and the Japan International Cooperation Agency (JICA) (SATREPS)

IRB Contact (For public release)
Organization	Ethics Committee of University of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
Tel	+81-029-853-3914
Email	chiken@un.tsukuba.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	International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Other administrative information
Date of disclosure of the study information	2020 Year 01 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
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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 28 Day
Last follow-up date	2023 Year 03 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	2019 Year 12 Month 27 Day
Last modified on	2020 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044500