Daily stress reduction through synbiotic food

UMIN ID: UMIN000055405

Registered date:05/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/09/05
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention group takes 2 packets of G fine, a synbiotics, per day for 4 weeks (with 100 ml water per packet)
Control group takes 100 ml of water twice a day

Outcome(s)

• Primary Outcome: salivary cortisol and alpha-amylase (before, after 2 weeks and 4 weeks intake)
• Secondary Outcome: intestinal flora, stool organic acid concentration, microbial metabolite concentration, skin condition, stress status

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 39years-old
• Gender: Male and Female
• Exclude criteria: 1) Those who are taking drugs such as antibiotics that affect digestion and absorption, 2) Those who have digestive disorders (including irritable bowel syndrome) or a history of surgery (excluding appendectomy) that affect digestion and absorption or defecation, 3) Those who have skin-related diseases, 4) Those who suffer from heart or kidney disease, diabetes or other serious diseases, 5) Those who are participating in other research or surveys, 6) Those who have a disordered diet such as extreme fasting or overeating, and 7) Those who have a history of certain health problems that may be related to bowel regulation. (5) Those who are participating in other research or investigation, (6) Those who are exposed to a large amount of ultraviolet rays on a daily basis, (7) Those who have a disordered diet such as extreme fasting or overeating, (8) Those who cannot stop additional intake of food for specified health use, functional foods, yogurt, lactic acid bacteria drinks, supplements or other food/beverage with possible functionality that is believed to be involved in the bowel regulating action, except for those who are unable to stop the intake of such foods or beverages. (viii) Those who are unable to stop the intake of foods/drinks that are considered to be involved in intestinal regulation, except for natto, which shall be prohibited during the study period, (ix) Those who have allergies (to foods related to the test foods), (x) Those who are pregnant, lactating, or intend to become pregnant during the study period. (11) Any other person whom the principal investigator deems inappropriate as a subject for this study.

Related Information

• Primary Sponsor: Kobe University Graduate School of Health Sciences
• Source(s) of Monetary Support: Kobe University Graduate School of Health Sciences