Tokyo, Nov. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063526) titled 'A Study to Evaluate the Effects of a Functional Beverage containing Lemon Juice on Cognitive Task-Induced Fatigue' on Nov. 9.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Integrated Health Science Co., Ltd.
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of a functional beverage on alleviating cognitive fatigue during computerized task performance.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion of the Test beverage
Interventions/Control_2 - Ingestion of the Control beverage
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1. Healthy female aged 20 to 59 years
2. Individuals who understand the informed consent information and are able to provide voluntary written consent
Key exclusion criteria - 1. Individuals employed by a food or pharmaceutical company.
2. Individuals with a history of neurological or cardiovascular disease, renal failure, or any other serious illness.
3. Individuals with a history of seizures (such as loss of consciousness, coma, or convulsions) due to neurological disorders.
4. Individuals currently receiving ongoing treatment or taking medication for any medical condition.
5. Individuals who have difficulty performing essential evaluation items in this study due to hearing or visual impairments.
6. Individuals with olfactory or taste disorders.
7. Individuals who are currently pregnant or breastfeeding.
8. Individuals with food allergies.
9. Individuals who dislike sour tastes.
10. Individuals who regularly consumed foods containing functional ingredients at least three times per week during the month prior to providing informed consent.
11. Individuals who consumed foods containing functional ingredients between 8:00 p.m. on the day before the study and the start of the study procedures.
12. Individuals who are currently participating in another clinical trial or who participated in another clinical trial within one month prior to providing informed consent.
13. Individuals judged as inappropriate for participation by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 18 Day
Date of IRB - 2026 Year 08 Month 19 Day
Anticipated trial start date - 2026 Year 11 Month 09 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072688
Disclaimer: Curated by HT Syndication.
