Human Absorption Study of Liposomal Glucosamine Supplements

September 21, 2026 updated by: TCI Co., Ltd.

Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Glucosamine Supplements

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Emulsified Liposomal Glucosamine Liquid

One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine.
Dietary supplement: High-Emulsified Liposomal 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.

Other Names:
  • High-Emulsified Double Nutri Glucosamine Liquid
Experimental: Low-Emulsified Liposomal Glucosamine Liquid

One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine.
Dietary supplement: Low-Emulsified Liposomal 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.

Other Names:
  • Low-Emulsified Double Nutri Glucosamine Liquid
Active Comparator: Glucosamine Liquid without Liposomal

One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine.
Dietary supplement: Glucosamine Liquid without Liposomal

The formulation primarily consists of glucosamine HCl and is not processed using the patented Double Nutri Liposomal technology.
Active Comparator: Glucosamine tablet without Liposomal

Three tablets will be administered per dose, with each tablet containing 500 mg of glucosamine.
Dietary supplement: Glucosamine Tablet without Liposomal

The tablet formulation primarily consists of glucosamine HCl and is not processed using liposomal technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma glucosamine level (ng/mL)
Time Frame: 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.
at 24 hours after taking test sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TCI Co., Ltd.

Investigators

  • Principal Investigator: Tong-Lin Wu, TCI Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 21, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 29, 2027

Study Registration Dates

First Submitted

September 21, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 28, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-088-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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