Verification of the effects induced by test-food intakes on gut microenvironment and IgA

UMIN ID: UMIN000044381

Registered date:02/06/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2021/06/02
• Target sample size: 68
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of the test food (50.0 g) with milk (200 mL) to the subject every morning, for 4 weeks.
Ingestion of the placebo food (57.3 g) with milk (200 mL) to the subject every morning, for 4 weeks.

Outcome(s)

• Primary Outcome: Fecal IgA level
• Secondary Outcome: 1. Gut microbiota 2. Gut metabolites 3. Nonspecific serum IgE 4. Food frequency questionnaire (short version of FFQ) 5. Body composition (body weight, internal water content, muscle mass, protein content, mineral content, body fat quantity, body fat percentage, skeletal muscle mass, basal metabolic rate, body mass index, InBody score, abdominal circumference, bone mineral content) 6. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor) 7. Changes in clinical examination value 8. Constipation assessment scale-mid term

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: (1)Subjects who take cereal more than 3 times a week. (2)Subjects who have a plan or who have taken medication within a month before the trial start, which would affect the trial result. (3)Subjects who are regularly consuming food for specified health uses, food with function claims, supplement and/or health foods which would affects the trial results for more than 3 times a week. (4)Subjects who cannot drink milk. (5)Subjects with lactose intolerance. (6)Subjects who had undergone appendectomy. (7)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (8)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (9)Subjects who are suspected of seriously chronic/acute infectious diseases. (10)Subjects who are planning to receive vaccination during this trial. (11)Pregnant, possibly pregnant, or lactating women. (12)Subjects who take excessive alcohol. (13)Subjects with smoking habit, now and/or within a year before this trial. (14)Subjects with irregular dietary habits. (15)Subjects whose roomer is planning to join this trial. (16)Subjects who are planning to change their life style considerably during this trial. (17)Subjects who have food allergies. (18)Subjects who are now under the other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial. (19-21)Subjects who donated their blood components and/or whole blood as below - all subjects: 200 mL within a month - males: 400 mL within the last 3 months - females: 400 mL within the last 4 months to this trial. (22-23)Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study; - males: 1,200 mL - females: 800 mL (24)Others who have been determined ineligible by principal/sub investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Calbee, Inc.