Research on the effect of eating chocolate on feeling of tension

UMIN ID: UMIN000054229

Registered date:26/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/05/07
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Research food are consumed one (standard 4 g) at a time
Not consuming research food

Outcome(s)

• Primary Outcome: subjective evaluation (tension)
• Secondary Outcome: subjective evaluation (restless state, awareness of others, sense of accomplishment), amount of sweating, heart rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Those who has sweaty hands and measurement difficulties (2) Those who are judged to be inappropriate as research subjects (subjects) based on their answers to the lifestyle questionnaire (3) Those who are judged to be unsuitable as subjects based on the answers to the background survey (4) Those who are suspected of having depression (5) Those who may develop allergies in relation to research food (6) Those who are prescribed or regularly use medications that may affect stress (7) Those who consume health foods such as specified health foods and functional foods related to stress at least one day per week (8) Those who doesn't like research food (9) Those who, due to injury or other reasons, have difficulty in measuring amount of sweating or inputting data into a computer (10) Those who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication (11) Those whose physical measurements, physical examination values, and clinical examination values before the examination were significantly out of the reference range (12) Those who work in shifts, work late at night, and have an irregular daily rhythm (13) Those who plan to go abroad during the study period, or who plan to make a domestic business trip, domestic travel, or return home during the 3 days prior to the Intake Phase I or Intake Phase II test date (14) Those who participated in other clinical studies, clinical trials, or human trials within one month prior to the start of this study (15) Those who plan to become pregnant or breastfeed during the study period (16) Those who are judged as unsuitable for the study by the investigator for other reason

Related Information

• Primary Sponsor: Lotte Co., Ltd.
• Source(s) of Monetary Support: Lotte Co., Ltd.