UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054886 |
|---|---|
| Receipt number | R000062704 |
| Scientific Title | Evaluation of the Effect of Food Ingredient Components on Satisfaction: A Randomized, Single-Blind, Crossover Comparison Study |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/10/16 10:52:09 |
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Basic information
Public title
Evaluation of the Effect of Food Ingredient Components on Satisfaction: A Randomized, Single-Blind, Crossover Comparison Study
Acronym
Evaluation of the Effect of Food Ingredient Components on Satisfaction
Scientific Title
Evaluation of the Effect of Food Ingredient Components on Satisfaction: A Randomized, Single-Blind, Crossover Comparison Study
Scientific Title:Acronym
Evaluation of the Effect of Food Ingredient Components on Satisfaction
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test hypotheses about the relationship between subjective satisfaction and biomarker response to the test beverages and caloric intake after consumption of the test beverages.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS for satiety
salivary markers
Key secondary outcomes
Sensory evaluation
Calorie intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single consumption of Test Beverage A.
Interventions/Control_2
Single consumption of Test Beverage B.
Interventions/Control_3
Single consumption of Test Beverage C,
Interventions/Control_4
Single consumption of Test Beverage D.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 to under 60 years old
2. Gender: Japanese men and women
3. Capable of inputting electronic questionnaires using smartphones or iPads
4. Habitually consume three meals a day (occasional skipping of meals 1-2 times per week is acceptable)
5. Provided informed consent after sufficient explanation of the study's objectives and content
Key exclusion criteria
1. Currently undergoing treatment for any disease (including medication and herbal remedies, except on an as-needed basis)
2. Experienced significant changes in lifestyle or environment within the month before consent (e.g., diet, sleep, exercise, relocation, unemployment, divorce, death of a spouse or relative)
3. Plans to significantly change lifestyle habits during the study period
4. Abnormalities in the sense of smell or taste
5. Having eating disorders or conscious dietary restrictions
6. Present with dry mouth, Sjogren's syndrome, or any other disease affecting salivary secretion
7. Current or past drug addiction
8. Present or past severe conditions of the liver, kidneys, heart, respiratory system, endocrine system, metabolic diseases (e.g., diabetes), gastrointestinal diseases, etc.
9. History of gastrointestinal surgery (excluding appendicitis)
10. Present or past drug or food allergies
11. Weighing less than 45 kg
12. Currently consuming commercial drugs, quasi-drugs, specific health foods, functional foods, health foods, or supplements and cannot abstain during the study period
13. Irregular lifestyle patterns (e.g., shift work, night work)
14. Current smokers or those who have smoked within the year before consent
15. Heavy alcohol consumers (pure alcohol intake of 40g or more per day)
16. Currently pregnant, breastfeeding, or planning to become pregnant during the study
17. Participated in other clinical studies within a month before consent or currently participating, or planning to participate during the study period
18. Individuals deemed unsuitable for participation by the principal investigator
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Higashi Koganei Sakura Clinic
Division name
Director
Zip code
184-0011
Address
4-37-26, Higashicho, Koganei-shi, Tokyo, Japan
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Sales department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality and Innovations, Ltd
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.co.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 10 | 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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062704
