UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052022 |
|---|---|
| Receipt number | R000059383 |
| Scientific Title | An examination into the acute effects of a nutraceutical beverage on mood and general wellbeing in healthy adults: A randomised-controlled crossover, pilot trial |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/03/06 15:56:38 |
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Basic information
Public title
An examination into the acute effects of a nutraceutical beverage on mood and general wellbeing in healthy adults: A randomised-controlled crossover, pilot trial
Acronym
An examination into the acute effects of a nutraceutical beverage on mood and general wellbeing in healthy adults: A randomised-controlled crossover, pilot trial
Scientific Title
An examination into the acute effects of a nutraceutical beverage on mood and general wellbeing in healthy adults: A randomised-controlled crossover, pilot trial
Scientific Title:Acronym
An examination into the acute effects of a nutraceutical beverage on mood and general wellbeing in healthy adults: A randomised-controlled crossover, pilot trial
Region
| Australia |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the acute effects of the single ingestion of a nutraceutical beverage on self-reported mood and general wellbeing in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological questionnaires
Key secondary outcomes
Heart beat
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food (200 mL) in 15 minutes
Interventions/Control_2
Ingestion of placebo food (200 mL) in 15 minutes
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age 20 to 39 years
2. Sex: approximately equal distribution of males and females
3. Healthy Caucasian
4. BMI between 18 to 30 kg/m2
5. Non-smokers (no history of smoking in the past year)
6. Have given written consent to participate in the study of their own free will after being fully informed of and understanding the study objective and content.
7. Understand, willing and able to comply with all study procedures
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Key exclusion criteria
1. Currently on treatment with any medicinal drugs or Chinese herbal medicines (on-demand medication is allowed.)
2. Have a history of or current serious cardiac, hepatic, renal, or gastrointestinal disorders
3. Have pollinosis or allergic rhinitis (seasonal or perennial)
4. Currently on dietary or exercise therapy under medical supervision
5. Routinely use over-the-counter drugs, quasi-drugs, foods for specified health uses, foods with functional claims, or functional foods, etc. which influence the autonomic nervous system, metabolism, or sleep (Subjects who can discontinue use of these products during the study after providing consent are permitted to participate in the study.)
6. Consume more than 6 standard drinks of alcohol per day
7. Have significant inconsistency in the timing of meals from day to day
8. Have an irregular sleep cycle (e.g. shift-workers/night workers)
9. Have participated in any other clinical trials within one month before providing consent, who are currently participating in any other clinical trials, or who intend to participate in any other clinical trials during or within four weeks of completion of this study
10. Have significant stress due to life events such as relocation, job change, or separation from close relatives within the three months before providing consent, or who have such life events expected to occur during this study
11. Have difficulty in abstaining from alcohol entirely from the day before the date when the study is conducted
12. Have allergy to medicines or foods
13. Pregnant or breastfeeding
14. Subjects who are considered ineligible for this study by the investigator
15. Have any problem with wearing the heart rate monitor (thick body hair on the chest, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Adrian |
| Middle name | |
| Last name | Lopresti |
Organization
Clinical Research Australia
Division name
Clinical Research Australia
Zip code
6023
Address
38 Arnisdale Rd Duncraig WA
TEL
+61894487376
adrian@clinicalresearch.com.au
Public contact
Name of contact person
| 1st name | Adrian |
| Middle name | |
| Last name | Lopresti |
Organization
Clinical Research Australia
Division name
Clinical Research Australia
Zip code
6023
Address
38 Arnisdale Rd Duncraig WA
TEL
+61894487376
Homepage URL
adrian@clinicalresearch.com.au
Sponsor or person
Institute
Clinical Research Australia
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & 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
National Institute of Integrative Medicine Human Research Ethics Committee
Address
11-23 Burwood Road, Hawthorn Victoria 3122 AUSTRALIA
Tel
(03) 9804 0646
hrec@niim.com.au
Secondary IDs
Secondary IDs
YES
Study ID_1
0126E_2023
Org. issuing International ID_1
National Institute of Integrative Medicine Human Research Ethics Committee
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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
40
Results
The test food showed psychological changes compared to the placebo food.
Results date posted
| 2025 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy male and female aged 20 to under 39 years old
Participant flow
53 participants were enrolled. Those who met the inclusion criteria were sequentially included in the clinical study.
Adverse events
Oral irritation observed with the placebo food(1 case).
Outcome measures
Psychological questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059383
