UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034976
Receipt No. R000039879
Scientific Title An investigation of mineral absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Date of disclosure of the study information 2018/11/22
Last modified on 2019/02/12

* 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 An investigation of mineral absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Acronym An investigation of mineral absorption
Scientific Title An investigation of mineral absorption: a randomized, double-blind, placebo-controlled, crossover trial.
Scientific Title:Acronym An investigation of mineral absorption
Region
Japan

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

Objectives
Narrative objectives1 To verify the effects of the intake of test food on minerals absorption on healthy Japanese adult subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Minerals in the blood, urine, and stool

*1 Assessed sodium, calcium, magnesium, and iron in minerals
*2 Collected blood samples at baseline, 30 min, 60 min, 90 min, and 120 min
*3 Collected urine at baseline, 2, 4, 6, 8, and 24 hours after intake
*4 Collected stool at 24 hours after intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: single dose
Test food: active food 1, active food 2, and placebo food
Administration: Eat test food with water during meal

<Intervention schedule A>
[1]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner.
[2]
Washout period is for 4 days.
[3]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner.
[4]
Washout period is for 4 days.
[5]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner.

<Intervention schedule B>
[1]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner.
[2]
Washout period is for 4 days.
[3]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner.
[4]
Washout period is for 4 days.
[5]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner.

*The allocation is performed according to Latin square. When intervention schedule A is applied, all intervention schedule B are rejected (vice versa).
Interventions/Control_2 Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule A>
[1]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner.
[2]
Washout period is for 4 days.
[3]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner.
[4]
Washout period is for 4 days.
[5]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner.

<Intervention schedule B>
[1]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner.
[2]
Washout period is for 4 days.
[3]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner.
[4]
Washout period is for 4 days.
[5]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner.

*The allocation is performed according to Latin square. When intervention schedule A is applied, all intervention schedule B are rejected (vice versa).
Interventions/Control_3 Duration: same as above
Test material: same as above
Administration: same as above

<Intervention schedule A>
[1]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner.
[2]
Washout period is for 4 days.
[3]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner.
[4]
Washout period is for 4 days.
[5]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner.

<Intervention schedule B>
[1]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with placebo food for breakfast. Eat the prescribed diet for lunch and dinner.
[2]
Washout period is for 4 days.
[3]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 2 for breakfast. Eat the prescribed diet for lunch and dinner.
[4]
Washout period is for 4 days.
[5]
Day 1: Eat the prescribed diet for breakfast, lunch, and dinner.
Day 2: Eat the prescribed diet with active food 1 for breakfast. Eat the prescribed diet for lunch and dinner.

*The allocation is performed according to Latin square. When intervention schedule A is applied, all intervention schedule B are rejected (vice versa).
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult men or menopause women for 1 or more year
2. Subjects who defecate every morning at their home
3. Subjects who can eat the prescribed diet for breakfast, lunch, and dinner
4. Subjects who have a regular bowel movement once a day in the morning
5. Subjects who can send their stool and urine after collecting stool in the morning
6. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, kidney stone, cerebrovascular disorder, rheumatism, diabetes mellitus, hypercalcemia, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who regularly take calcium-rich foods such as calcium-fortified milk
5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
6. Subjects who have physical labor in perspiration
7. Subjects who work late-night shift and the lifestyles are irregular
8. Subjects who cannot control their room temperature including not having any air conditioners and heaters
9. Subjects who have a tendency toward constipation or diarrhea
10. Subjects who have excessive fitness habit
11. Subjects who have a drinking habit
12. Subjects who are currently taking medications (including herbal medicines) and dietary supplements
13. Subjects who are an allergic reaction to medications and/or the test food related products
14. Subjects who are pregnant, breast-feeding, or planning to become pregnant
15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization San-ei Sucrochemical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 22 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 22 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039879

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.