Study to verify the efficacy of the intestinal regulating effect of the intake of seabuckthorn Juice.

UMIN ID: UMIN000055660

Registered date:01/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 2024/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of seabuckthorn juice
Intake of placebo juice

Outcome(s)

• Primary Outcome: Number of days of defecation, frequency of defecation
• Secondary Outcome: Defecation volume, distribution of intestinal flora (bacterial flora), shape of defecation, stool color, odor, sensation after defecation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: (1) Those with a confirmed diagnosis of constipation and chronic constipation or those who meet the criteria of the Guidelines for the Treatment of Chronic Constipation 2017. (2) Persons who consume foods or health foods listed as containing seabuckthorn Juice, the food under study. (3) Persons who regularly use medicines, health foods, foods for specified health uses, foods with functional claims (non-digestible dextrin, chitosan, oligosaccharides, etc.) that may affect bowel movements (4) Persons who are determined to be lactose intolerant, including self-reported lactose intolerance (5) Persons who habitually consume dietary supplements or dietary supplements related to immune function (6) Patients who are visiting the hospital or using drugs or over-the-counter laxatives for bowel movement-related diseases at the time of participation in the study (7) Have a disease or pre-existing condition that is considered to significantly affect bowel movements, such as irritable bowel disease or ulcerative colitis. (8) Those who work night shifts or day/night shifts (9) Patients who are undergoing treatment at a medical institution for treatment or prevention of disease, or whose condition is judged to be in need of treatment at the time of obtaining consent. (10) Those with a history of serious diseases of the glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system, or psychiatric diseases (11) Those with a history of alcohol and drug dependence (12) Persons who are at risk of developing allergies to foods (13) Pregnant or lactating at the time consent is obtained, or wishes to become pregnant during the study period (14)Persons who are deemed by the investigator (or the study investigator) to be unsuitable to participate in the study.

Related Information

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