Clinical Trial: A randomized, double-blind, crossover study on the effects of flavor differences in food on emotional and physiological indices (Japan)

Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060370) titled 'The effects of flavor differences in food on the mind' on Jan. 15.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Macromill, Inc.

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A randomized, double-blind, crossover study will be conducted in healthy subjects to examine the effects of a single intake of the test food on emotional and physiological indicators. Basic objectives2 - Others

Intervention: Interventions/Control_1 - A single intake of the test food (4g) in Phase I. After a washout period of at least one day, a single intake of the control food (4g) in Phase II. After another washout period of at least one day, in Phase III, a single intake of the practice food (4g) or the corresponding the sample (4g) if there was an issue during measurement in either Phase I or II. Subsequently, for paired comparison test, a single intake of the test food(4g) followed by a single intake of the control food (4g). Interventions/Control_2 - A single intake of the control food (4g) in Phase I. After a washout period of at least one day, a single intake of the test food (4g) in Phase II. After another washout period of at least one day, in Phase III, a single intake of the practice food (4g) or the corresponding the sample (4g) if there was an issue during measurement in either Phase I or II. Subsequently, for paired comparison test,a single intake of the control food(4g) followed by a single intake of the test food (4g).

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Adult men and women aged 20 to 69 at the time of consent (2) Those who don't dislike milk chocolate (3) Those who self-report healthy (4) Those who have received sufficient information about the purpose and content of this study, are competent to consent, can fully understand the content, and can give their own consent through electromagnetic informed consent. Key exclusion criteria - (1)Those who currently receiving medical treatment or medication from a doctor for any disease (chronic diseases such as diabetes or high blood pressure, digestive diseases such as gastrectomy, gastric ulcers or reflux esophagitis, malignant tumors, kidney disease, heart disease, etc.) (2)Those who currently taking or using any medication, including prescription or over-the-counter medications (excluding emergency medications) (3)Those who with taste disorders, hay fever or rhinitis symptoms (4)Those who are using medication for runny nose or nasal congestion (5)Those who using pacemakers (6)Those who with chronic oral diseases or symptoms (7)Those who undergoing dental treatment or wearing orthodontic appliances that may affect the evaluation (8)Those who are allergic to dairy or soy ingredients (9)Those who regularly use foods for specified health uses, functional foods, health foods, etc. that affect the autonomic nervous system (10)Those who have experienced a life event such as moving, changing jobs, or separation from a close relative within the three months prior to obtaining consent and may be under significant stress, or subjects who are scheduled to experience a similar life event during the study period. (11)Those who are planning to travel or go on a business trip of 7 days or more between October 2025 and March 13, 2026, or who may go on a business trip or travel (12)Those who Regular alcohol users: Generally, more than 60g of alcohol per day (13)Those who with extremely irregular sleeping or eating habits (14)Those who are currently participating in another clinical trial, or have participated within the past four weeks of obtaining consent, or those who plan to participate in another clinical trial during the study period (15)Women who are breastfeeding, pregnant, possibly pregnant, or intend to become pregnant during the study period (16)Other subjects who are judged by the investigator to be ineligible to be subjects Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 24 Day Date of IRB - 2025 Year 12 Month 24 Day Anticipated trial start date - 2026 Year 01 Month 16 Day Last follow-up date - 2026 Year 03 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069031

Disclaimer: Curated by HT Syndication.