UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054864 |
|---|---|
| Receipt number | R000062643 |
| Scientific Title | Effects of pre-meal gum chewing and flavour on subsequent appetite and food intake |
| Date of disclosure of the study information | 2024/07/04 |
| Last modified on | 2025/01/02 10:00:15 |
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Basic information
Public title
Effects of pre-meal gum chewing and flavour on food intake
Acronym
Effects of gum chewing and flavour on appetite
Scientific Title
Effects of pre-meal gum chewing and flavour on subsequent appetite and food intake
Scientific Title:Acronym
Effects of gum chewing and flavour on subsequent appetite and food intake
Region
| Japan |
Condition
Condition
Heathy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study assesses the effects of pre-prandial gum chewing and its flavour on food preferences, subjective appetite and energy intake in healthy men aged between 18 and 30 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy intake, Subjective appetite, Food reward
Key secondary outcomes
Physical function, Resting metabolic rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Appetite measurements are taken through the paper- and computer-based questionnaires before and after rest (no prescribed gum), followed by the assessment of energy intake and food selection during a buffet-style meal.
Interventions/Control_2
Appetite measurements are taken through the paper- and computer-based questionnaires before and after chewing prescribed gum (unflavoure), followed by the assessment of energy intake and food selection during a buffet-style meal.
Interventions/Control_3
Appetite measurements are taken through the paper- and computer-based questionnaires before and after chewing prescribed gum (mint flavoure), followed by the assessment of energy intake and food selection during a buffet-style meal.
Interventions/Control_4
Appetite will be measured through the paper- and computer-based questionnaires before and after chewing prescribed gum (savoury flavoure), followed by the assessment of energy intake and food selection during a buffet-style meal.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Age between 18 and 30 years old
2. Non-smoker
3. A participant who did not perform weight changes plus or minus 3 kg in the past six - twelve months and who has no intention to weight loss during the study
4. Not taking any medication (including supplements)
5. Not participating in other studies while participating in the present study
6. Not suffering from diseases affecting appetite
7. No allergy to the food or gum provided.
8. Those who do not have the habit of chewing gum (chewing gum for less than 30 minutes/week)
9. A person who eats breakfast regularly every morning.
Key exclusion criteria
1. Age range outside the selection criteria
2. Smoker
3. A participant who performed weight changes plus or minus 3 kg in the past six - twelve months and who has an intention to weight loss during the study
4. Have the habit of chewing gum (those who chew gum for more than 30 minutes/week)
5. Taking medication (including supplements)
6. Suffering from diseases affecting appetite
7. Those who plan to become participants of other research while participating in the present study or those who are already participated other studies
8. A participant who is allergic to the food or gum provided, or have a strong aversion to them
9. Regularly skip breakfast or do not eat at all
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Waseda University
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062643
