Human Absorption Study of Liposomal Glucosamine Supplements

This study is a single-center, self-controlled crossover human trial designed to evaluate the differences in blood concentration changes and bioavailability following a single oral dose of glucosamine supplements.

Healthy adult participants aged 18 years and older will be enrolled. Each participant will complete four study sessions, with a minimum washout period of 7 days between sessions. On each study day, venous blood samples will be collected prior to test product administration (0 minutes) to assess glucosamine levels, complete blood count, blood lipids, blood glucose, and liver and kidney function indicators.

After baseline blood collection, a standardized breakfast will be provided and consumed within 10 minutes, followed by administration of the test product. Venous blood samples will then be collected at 0.5, 1, 2, 4, 8, and 24 hours post-intake to measure glucosamine concentrations. Lunch will be provided after the 4-hour blood draw, and dinner will be provided after the 8-hour blood draw. Identical meals will be provided on four study sessions.

• High-Emulsified Liposomal Glucosamine Liquid (Dietary supplement), also known as High-Emulsified Double Nutri Glucosamine Liquid: The 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 supplement), also known as Low-Emulsified Double Nutri Glucosamine Liquid: The 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 supplement): The formulation primarily consists of glucosamine HCl and is not processed using the patented Double Nutri Liposomal technology.
• Glucosamine Tablet without Liposomal (Dietary supplement): The tablet formulation primarily consists of glucosamine HCl and is not processed using liposomal technology.

Primary outcomes

• Plasma glucosamine level (ng/mL) [at 24 hours after taking test sample]: Plasma glucosamine levels will be measured at fasting and at 0.5, 1, 2, 4, 8, and 24 hours post-intake.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Individuals with a history of gastrointestinal surgery, organ transplantation, or other major surgery.
* Individuals who have experienced acute gastroenteritis within 2 weeks prior to study initiation.
* Individuals with a history of allergy to any ingredient in the investigational products. The investigational products contain shrimp- and soy-derived ingredients.
* Vegetarians, as the glucosamine used in this study is derived from shrimp.

• Tong-Lin Wu, Principal investigator, TCI Co., Ltd.