Tokyo, Aug. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058869) titled 'Social Effects of Food Ingredients Evaluation' on Aug. 23.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the communication effects of food ingredients in humans, the study on the subjective assessment of psychological impact and objective assessment to support the subjective assessment will be conducted.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Control beverage will be ingested over a period of 20 minutes.
Interventions/Control_2 - Study beverage will be ingested over a period of 20 minutes.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - 1. Aged 20 to under 35 at the time of informed consent.
2. Japanese male
3. Those who usually drink alcoholic beverages but intend to reduce or stop drinking, or those who do not usually drink alcoholic beverages.
4. Those who have no history of alcoholism or other psychiatric or neurological related problems (including family history)
5. Those who can drink 200ml of sweet lemon-flavored carbonated beverage in 20 minutes without difficulty.
6. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria - 1. Those who have history of alcoholism, caffeine addiction, or other mental or neurological problems
2. Those who has a problem with wearing heart rate meters
3. Judged by the investigator to be unsuitable for participating in this study
Target Size - 72
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 08 Month 22 Day
Date of IRB - 2025 Year 08 Month 14 Day
Anticipated trial start date - 2025 Year 08 Month 23 Day
Last follow-up date - 2025 Year 09 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067323
Disclaimer: Curated by HT Syndication.
