UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055646 |
|---|---|
| Receipt number | R000063595 |
| Scientific Title | The acute effects of a nutraceutical beverage on mood, energy and wellbeing in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial |
| Date of disclosure of the study information | 2025/09/29 |
| Last modified on | 2025/03/06 13:34:38 |
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Basic information
Public title
The acute effects of a nutraceutical beverage on mood, energy and wellbeing in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial
Acronym
The acute effects of a nutraceutical beverage on mood, energy and wellbeing in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial
Scientific Title
The acute effects of a nutraceutical beverage on mood, energy and wellbeing in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym
The acute effects of a nutraceutical beverage on mood, energy and wellbeing in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial
Region
| Australia |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the acute effects of the single ingestion of a test beverage on self-reported mood and cognition in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire assessing psychological factors
Key secondary outcomes
1. Questionnaire assessing taste, aroma, and flavour of test beverage
2. Self-reported adverse effects
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo beverage will be ingested over a period of 15 minutes.
Interventions/Control_2
Study beverage will be ingested over a period of 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 by 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 from 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
80
Research contact person
Name of lead principal investigator
| 1st name | Adrian |
| Middle name | |
| Last name | Lopresti |
Organization
Clinical Research Australia
Division name
Operational Lead
Zip code
6023
Address
38 Arnisdale Rd Duncraig WA, Australia
TEL
+61-8-9448-7376
adrian@clinicalresearch.com.au
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Takagi |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Laboratories
Zip code
302-0106
Address
1-1-21 Midori, Moriya-shi, Ibaraki, Japan
TEL
+81-80-7740-3960
Homepage URL
marina.takagi@asahi-qi.co.jp
Sponsor or person
Institute
Clinical Research Australia
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd
Organization
Division
Category of Funding Organization
Self funding
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 Rd Hawthorn Melbourne VIC 3122 Australia
Tel
+613-9912-9586
hrec@niim.com.au
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
| 2025 | Year | 09 | Month | 29 | 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
79
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 | 08 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 09 | Month | 27 | 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=R000063595
