Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055646) titled 'The acute effects of a nutraceutical beverage on mood, energy and wellbeing in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial' on Sept. 29.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Clinical Research Australia
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 80
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063595
Disclaimer: Curated by HT Syndication.
