Efficacy of OPTIMEALTH FOOD on Gut health

Not Applicable

Completed

• Conditions: Improvement of constipation symptoms; Digestive System

• Registration Number: ISRCTN16659746
• Lead Sponsor: INNOVATION LABO SCIENCES Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-05
• Study Start: 2024-08-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Healthy adult subjects between 21 and 65 years (inclusive) of age
2. General symptoms of constipation and meet ROME III criteria for functional constipation
3. 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. Willing to give written informed consent and be willing to comply with trial protocol
6. The ability to understand the risks/benefits of the protocol
7. Available for the duration of the study period (6 weeks)

Exclusion Criteria

1. Constipation due to organic or neurological lesions
2. A history of pathological bowel diseases like IBD or colon cancer
3. Abnormal liver or renal function
4. Taken any prebiotic, probiotic or laxative supplements within 8 weeks from the start of the study period
5. Receiving any antibiotic, anti-inflammatory or immunosuppressive drug within the past 4 weeks
6. Known allergies to soy milk or any other test product ingredients
7. Alcoholics and or drug abusers
8. Pregnant or lactating females
9. A history of anxiety or depression or recent intake of psychotropic drugs
10. Any other condition which the Principal Investigator thinks may jeopardize the study outcome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Defecation frequency self-assessment measured using a daily chart at baseline and week 4

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures are assessed at baseline and week 4:<br>1. Stool consistency by self-assessment measured using the Bristol stool chart<br>2. Constipation-related symptom scores measured using a self-assessment questionnaire<br>3. Stool short-chain fatty acid (SCFA) content measured using gas chromatography<br>4. Gut microbiota composition measured using quantitative PCR<br>5. Oxidative biomarker levels in blood measured using a ferric reducing antioxidant power (FRAP) assay