Constipation Digestive System
Conditions
Interventions
This study investigates 4 weeks of daily supplementation with OPTIMEALTH Food P 500 (300 mg/day, 150 mg x 2 capsules) or a placebo (dextrin, 300 mg/day, 150 mg x 2 capsules) taken orally at breakfast.
Sponsors
INNOVATION LABO SCIENCES Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult male and female subjects between 21 to 65 years (inclusive) of age 2. Subjects with general symptoms of constipation and meet ROME IV criteria for functional constipation 3. Subjects with BMI between 18.5 and 29.9 kg/m² 4. Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result at the screening visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy 5. Subjects must be willing to give written informed consent and be willing to comply with the trial protocol 6. Subjects must have the ability to understand the risks/benefits of the protocol 7. Subjects should be available for the total duration of the study period (6 weeks)
Exclusion criteria
Exclusion criteria: 1. Subjects with constipation due to organic or neurological lesions 2. Subjects with a history of pathological bowel diseases like IBD or colon cancer 3. Subjects with abnormal liver or renal function 4. Subjects who have taken any prebiotic, probiotic or laxative supplements within 8 weeks of the start of the study period 5. Subjects receiving any antibiotic, anti-inflammatory or immunosuppressive drug within the past 4 weeks 6. Subjects who have any known allergies to soy milk or any other ingredients of the test product 7. Alcoholics and drug abusers 8. Pregnant or lactating females 9. Subjects with a history of anxiety or depression or recent intake of psychotropic drugs 10. Any other condition that the Principal Investigator thinks may jeopardize the study outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency self-assessment measured using a daily chart at baseline and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/09/2025: The following secondary outcome measures are assessed at baseline and week 4: 1. Stool consistency by self-assessment measured using the Bristol stool chart at baseline and end of study period 2. Constipation-related symptom scores measured using a self-assessment questionnaire at baseline and end of study period 3. Stool short-chain fatty acid (SCFA) content measured using gas chromatography in fecal samples collected at baseline and end of study period. 4. Gut microbiota composition measured using 16sRNA analysis in fecal samples collected at baseline and end of study period. 5. Antioxidant activity is tested using enzymatic and chemical assays. Blood samples were collected at baseline and end of study period and analyzed for SOD, GPx and CAT along with Total Antioxidant Capacity. 6. Inflammatory markers in saliva samples analysed using ELISA at baseline and the end of the study period Previous secondary outcome measures: The following secondary outcome measures are assessed at baseline and week 4: 1. Stool consistency by self-assessment measured using the Bristol stool chart at baseline and end of study period 2. Constipation-related symptom scores measured using a self-assessment questionnaire at baseline and end of study period 3. Stool short-chain fatty acid (SCFA) content measured using gas chromatography in fecal samples collected at baseline and end of study period. 4. Gut microbiota composition measured using quantitative PCR in fecal samples collected at baseline and end of study period 5. Antioxidant activity is tested using enzymatic and chemical assays. Blood samples were collected at baseline and end of study period and analyzed for SOD, GPx and CAT along with Total Antioxidant Capacity. 6. Inflammatory markers in saliva samples analysed using ELISA at baseline and the end of the study period | — |
Countries
Switzerland
Contacts
Public ContactAki Honda
Outcome results
None listed