UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054852 |
|---|---|
| Receipt number | R000062671 |
| Scientific Title | Effect of Artificially Sweetened Soft Drinks Consumption on Dietary Intake in Female University Students. |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2024/07/02 13:53:40 |
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Basic information
Public title
Effect of Artificially Sweetened Soft Drinks Consumption on Dietary Intake in Female University Students.
Acronym
Effect of Artificially Sweetened Soft Drinks Consumption on Dietary Intake
Scientific Title
Effect of Artificially Sweetened Soft Drinks Consumption on Dietary Intake in Female University Students.
Scientific Title:Acronym
Effect of Artificially Sweetened Soft Drinks Consumption on Dietary Intake
Region
| Japan |
Condition
Condition
Healthy female university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the impact of artificially sweetened soft drinks and energy-sweetened sugar-sweetened soft drinks on dietary intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in dietary intake between artificially sweetened soft drinks and sugar-sweetened soft drinks on days 4 and 5 of intake (weighing and recording method)
Key secondary outcomes
Continuous blood glucose measurement with artificially sweetened and sugar-sweetened drinking water, and whether there is a difference in the average daily value or range of variation.
Change in dietary intake of artificially sweetened soft drinks and sugar-sweetened soft drinks according to sweet taste perception and exercise habits.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The test beverage is Coca-Cola and one plastic bottle (500 mL) is consumed per day for 5 consecutive days.
Interventions/Control_2
The test beverage is Coca-Cola Zero and one plastic bottle (500 mL) per day is consumed for 5 consecutive days.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
3rd and 4th graders in the dietitian training program
Key exclusion criteria
The participants who have a special disease
Those with a weight change of more or less than 3 kg within 3 months.
Smokers
The participants who cannot drink Coca-Cola and Coca-Cola Zero.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences, Department of Food and Health Sciences
Zip code
813-8529
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
TEL
092-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences, Department of Food and Health Sciences
Zip code
813-8529
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
TEL
092-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Fukuoka Women's University
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
Tel
092-661-2411
soumu@fwu.ac.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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062671
