UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Title of the study (Brief title)	Effect of calcium combination lemon drink absorption on lifestyle-related disease.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Cardiology Endocrinology and Metabolism Neurology Geriatrics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It influences an oxidation stress and an age- related disease including lifestyle-related disease by absorption of the drink which included calcium richly and blended lemon juice by a longitudinal study clearly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time:11 months later 1. Subjective-objective symptom by a questionnaire 2. Somatometry 3. Blood pressure 4. Bone mineral density 5. Bone metabolism marker 6. Oxidation stress marker
Key secondary outcomes	glucose and lipid metabolism Hepatic Function Female hormone Fatigue

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Calcium combination lemon drink Period: 11 months Volume: 30 ml of lemon fruit juice and calcium 35 mg per one bottle Frequency: 1 bottle/day
Interventions/Control_2	Calcium combination drink Period: 11 months Volume: 30 ml of lemon fruit juice per one bottle Frequency: 1 bottle/day
Interventions/Control_3	No drink
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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	healthy female
Key exclusion criteria	1.Person doing warfarin medicine treatment. 2.Person with the severe disease medical history. 3.The person who judged that a test responsibility doctor was unsuitable.
Target sample size	90

Research contact person
Name of lead principal investigator	Toshihide Harada
Organization	Prefectural University of Hiroshima
Division name	Faculty of Health and Welfare
Address	1-1 gakuen-machi Mihara, Hiroshima, Japan
TEL	0848-60-1257
Email	hartoshi@pu-hiroshima.ac.jp

Public contact
Name of contact person	Hiromi Ikeda
Organization	Prefectural University of Hiroshima
Division name	Faculty of Health and Welfare
Address	1-1 gakuen-machi Mihara, Hiroshima, Japan
TEL	0848-48-1180
Homepage URL
Email	hikeda@pu-hiroshima.ac.jp

Sponsor
Institute	Prefectural University of Hiroshima
Institute
Department

Funding Source
Organization	Prefectural University of Hiroshima
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	POKKA SAPPORO FOOD & BEVERAGE LTD.
Name of secondary funｄer(s)

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	県立広島大学（広島県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 10 Day
Anticipated trial start date	2015 Year 12 Month 10 Day
Last follow-up date	2016 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 09 Day
Last modified on	2017 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021926