Tokyo, Dec. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058908) titled 'An investigation on the effect of glucosamine intake on gut environments' on Dec. 7.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - SOUKEN Co., Ltd.
Condition:
Condition - Constipation tendency in adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect of glucosamine intake on improving the intestinal environment.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of glucosamine 3000mg per day for 14 days
Interventions/Control_2 - Intake of placebo 3000mg per day for 14 days
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Japanese men and women aged 20 to 59 years at the time of consent.
2) Individuals capable of consistently taking 10 or more supplement tablets per day (can be divided into multiple doses).
3) Individuals with a bowel movement frequency of 3 to 5 times per week.
4) Individuals able to store stool samples collected at home in their refrigerator or freezer for several days until their visit.
Key exclusion criteria - 1) Individuals with alcohol dependency
2) Individuals taking medications that may influence the study results (e.g., drugs with intestinal regulatory effects, antibiotics, etc.)
3) Individuals routinely consuming health foods that may affect the study results (e.g., supplements containing lactic acid bacteria, oligosaccharides, or those claiming intestinal regulatory effects)
4) Individuals with potential allergy symptoms to test product components (especially shrimp or crab)
5) Individuals participating in other clinical trials
6) Individuals with a history of severe liver, kidney, or heart disease
7) Individuals with a history or current diagnosis of hepatitis
8) Individuals with a history or current diagnosis of diabetes
9) Individuals with a history or current diagnosis of thrombosis
10) Individuals with severe anemia
11) Pregnant women, women who may be pregnant, and breastfeeding women
Target Size - 40
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 07 Month 10 Day
Date of IRB - 2025 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 08 Month 06 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067265
Disclaimer: Curated by HT Syndication.