UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025811
Receipt No. 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 (Ver. 7)

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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
Email 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
Email yanagimoto.aya@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029680