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A human study for evaluating effectiveness and safety of GPX on gut immunity

A human study for evaluating effectiveness and safety of GPX on gut immunity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005913
Enrollment
116
Registered
2021-02-19
Start date
2021-02-22
Completion date
Unknown
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Applicants who sign the consent form for human study at visit 1 (week 2) will be judged for suitability according to the criteria for selection and exclusion. The selected subject

Sponsors

Ewha Womens University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subject who voluntarily agree to participate and signs informed consent form 2) Age more than 20-year-old and less than 65 years old 3) BMI = 23 kg/m2 4) Subject with a waist circumference of Male = 90 cm, Female = 85 cm 5) Subject who has had diarrhea or constipation symptoms at least once a week in the past month

Exclusion criteria

Exclusion criteria: 1) Subjects with the following diseases: - Intestinal diseases (Crohn's disease, colon cancer, celiac disease, inflammatory bowel disease IBD, etc.) - Patients with a history of lactose intolerance, gastrointestinal surgery (gastrointestinal duct surgery, etc.) - Thyroid disease, multiple sclerosis, spinal trauma, Cushing's syndrome, hyperlipidemia, cerebrovascular disease, cardiovascular disease, etc. - Severe central nervous system disorders requiring hospitalization or medication (dementia, Parkinson's disease, etc.) 2) Those who fall under the following - Consistent intake of antibiotics for more than a week within 4 weeks before the first visit - Temporarily took nonsteroidal anti-inflammatory drugs, corticosteroids, an immunosuppressive drug, etc. within 2 weeks before the first visit, or continuously took the drug within 12 weeks of before the first visit. - Antibacterial treatment within 6 weeks before the first visit. - Ingestion of appetite suppressants/stimulants, antidepressants, diuretics/beta-blockers, contraceptives, hormone drugs, etc. within 4 weeks before the first visit 3) High intake of antioxidant nutrients and dietary fiber 4) Continue to consume products containing ingredients that affect intestinal health within 4 weeks before the first visit. 5) Performing regular high-intensity exercise continuously. 6) Participated in a commercial obesity program or received a calorie restriction diet treatment within 12 weeks before the first visit. 7) Over 5% weight change within 12 weeks before the first visit. 8) Smoker 9) Heavy drinker 10) Hypersensitivity to the ingredients contained in the study product, or there is a severe food allergic reaction experience. 11) Subject who has difficulty to handle smartphone or computer 12) Participation in other human studies within 1 month before the first visit 13) Planning to be pregnant, Pregnant, or lactating women 14) Any condition that the principal investigator believes may put the subjects at under risk

Design outcomes

Primary

MeasureTime frame
Intestinal health improvement indicator

Secondary

MeasureTime frame
Clinical pathology indicator(vital signs, clinical laboratory test);Clinical pathology indicator(adverse events)

Countries

Korea, Republic of

Contacts

Public ContactYeaeun Nam

Ewha Womens University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026