UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025811 |
|---|---|
| Receipt number | R000029680 |
| Scientific Title | Effect of a plant derived food on energy metabolism in healthy women |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2020/02/18 18:38:00 |
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Basic information
Public title
Effect of a plant derived food on energy metabolism in healthy women
Acronym
Effect of a plant derived food on energy metabolism in healthy women
Scientific Title
Effect of a plant derived food on energy metabolism in healthy women
Scientific Title:Acronym
Effect of a plant derived food on energy metabolism in healthy women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of a plant derived food on energy metabolism in healthy women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medical examination regarding basal metabolic rate (supine position) and resting energy expenditure after 2 weeks intervention
Key secondary outcomes
respiratory quotient, fat utilization, carbohydrate utilization, analysis of blood and urine
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control food 2 weeks consumption > wash out 2 weeks > test food 2 weeks consumption
Interventions/Control_2
Test food 2 weeks consumption > wash out 2 weeks > control food 2 weeks consumption
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Age>=45 and <65 years
(2)Subjects who have given written informed consent prior to start of study
Key exclusion criteria
(1)Subjects who have a history or signs of a heart or cerebrovascular disease
(2)Subjects having diabetes, a liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases
(3)Subjects who take an antidiabetic drug or antihyperlipidemic drug
(4)Subjects having thyroid deficiency
(5)Subjects who have a smoking habit
(6)Heavy drinker
(7)Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the study
(8)Subjects who have severe anemia (Hb <=7g/dL)
(9)Subjects who have been to get sick by collecting venous blood
(10)Subjects who have allergic reaction to food
(11)Subjects who have sensitivity to control or test food
(12)Subjects who are planned to participate in other clinical study during current study
(13)Subjects who are pregnant, breast-feeding or have a pregnancy intention during the test period
(14)Subjects having menstrual irregularity
(15)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Osaki |
Organization
Kao Corporation
Division name
Health Care Food Research Laboratories
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
03-5630-7224
osaki.noriko@kao.co.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yanagimoto |
Organization
Kao Corporation
Division name
Health Care Food Research Laboratories
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
03-5630-7266
Homepage URL
yanagimoto.aya@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
Tel
03-5630-9220
morisaki.naoko@kao.com
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
https://rd.springer.com/article/10.1007%2Fs00394-019-01976-9
Number of participants that the trial has enrolled
14
Results
Significant difference in the primary outcome between the groups
Results date posted
| 2020 | Year | 02 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy women
Participant flow
13 completed the trial and 10 were analyzed.
Adverse events
None associated with the test beverage consumption
Outcome measures
Medical examination regarding basal metabolic rate (supine position) and resting energy expenditure after 2 weeks intervention
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2017 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029680
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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