Human Absorption Study of Liposomal Glucosamine Supplements
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTCI Co., Ltd.
About this trial
The objective of this study is to evaluate the effects of liposomal encapsulation using different ratios of gum arabic and lecithin on the bioavailability of a liquid glucosamine supplement in humans.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged ≥18 years, regardless of sex, who are willing to sign the informed consent form and are able to fully comply with all study procedures.
Disqualifiers
Pregnant or breastfeeding women, or individuals who are unwilling to use a physical method of contraception during the study period, such as condoms or an intrauterine device.
Employees of TCI Co., Ltd. and their family members.
Individuals who have regularly taken any supplements or medications containing glucosamine or N-acetylglucosamine (N-acetyl-glucosamine) within 14 days prior to study initiation, defined as use for ≥7 consecutive days.
Individuals with a history of chronic gastrointestinal disorders, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), chronic diarrhea, Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, or ulcerative colitis; a history of epilepsy or seizures; liver or kidney disease; malignancy; endocrine disorders; psychiatric disorders; alcohol or substance abuse; or other significant organic diseases, as determined based on medical history.
Trial design
Design model
Crossover
Treatments tested in this trial
High-Emulsified Liposomal Glucosamine Liquid
Dietary supplementThe formulation primarily consists of glucosamine HCl, a high proportion of soy lecithin, and gum arabic, and is processed using the patented Double Nutri Liposomal technology.
Low-Emulsified Liposomal Glucosamine Liquid
Dietary supplementThe formulation primarily consists of glucosamine HCl, a low proportion of soy lecithin, and gum arabic, and is processed using the patented Double Nutri Liposomal technology.
Glucosamine Liquid without Liposomal
Dietary supplementThe formulation primarily consists of glucosamine HCl and is not processed using the patented Double Nutri Liposomal technology.
Glucosamine Tablet without Liposomal
Dietary supplementThe tablet formulation primarily consists of glucosamine HCl and is not processed using liposomal technology.
Treatment groups
16 Participants
are divided into 4 treatment groupsGroup A: High-Emulsified Liposomal Glucosamine LiquidExperimental treatment 1 intervention
Group B: Low-Emulsified Liposomal Glucosamine LiquidExperimental treatment 1 intervention
Group C: Glucosamine Liquid without LiposomalActive comparator 1 intervention
Group D: Glucosamine tablet without LiposomalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plasma glucosamine level (ng/mL)
Plasma glucosamine levels will be measured at fasting and at 0.5, 1, 2, 4, 8, and 24 hours post-intake.
Time frame
at 24 hours after taking test sampleSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov