Healthy adults with a tendency toward constipation
Conditions
Interventions
Consume test food for 14 days ->
14-day break ->
Consume control food for 14 days
Consume control food for 14 days ->
Consume test food for 14 days
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese men and women aged 20 to 60 who had 3 to 5 bowel movements per week according to the research subject diary submitted at the time of the screening test. 2)Those who normally eat three meals a day. 3)Those who have received sufficient explanation about the purpose and content of the study, have the capacity to consent, have a good understanding of the study, have voluntarily applied to participate, and have agreed to participate in this study in writing.
Exclusion criteria
Exclusion criteria: 1)Those who regularly use laxatives or constipation medications (including purgatives). 2)Those with severe liver, kidney, gastrointestinal, heart, respiratory, endocrine, thyroid, or adrenal disease, or other metabolic disorders. 3)Those diagnosed with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD). 4)Those with a history of digestive tract diseases that affect digestion, absorption, or bowel movements, or a history of surgery. 5)Those with a history of or currently suffering from drug or alcohol dependence. 6)Those who cannot refrain from consuming foods containing live bacteria (e.g., lactobacillus, bifidobacteria, natto bacteria), foods enriched with oligosaccharides or dietary fiber, fermented foods, or foods containing large amounts of sugar alcohols during the study period. 7)Those who regularly take supplements claimed to improve constipation (including specific health use foods and functional foods) at the time of screening. 8)Those who have taken antibiotics or other medications that affect digestion and absorption within two weeks of screening. 9)Those with a habit of consuming excessive amounts of alcohol exceeding 40g of pure alcohol per day. 10)Shift workers or night shift workers. 11)Those deemed unsuitable as study participants based on the results of the study participant background questionnaire. 12)Pregnant those, those intending to become pregnant during the study period, or breastfeeding those. 13)Those who have undergone blood draws exceeding 200mL within one month or 400mL within three months prior to the date of informed consent. 14)Those currently participating in or intending to participate in studies involving the consumption of other foods, the use of medications, or the application of cosmetics or medications. 15)Other those deemed inappropriate as study participants by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Defecation days 2)Amount of stool 3)Shape of stool 4)Color of stool 5)Smell of stool 6)Feeling after bowel movement | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed