Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000910303p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
6/07/2026
Date registered
Help: Date registered
23/07/2026
Date last updated
Help: Date last updated
23/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Bioavailability of chondroitin sulfate sodium from bovine and vegetarian sources in healthy adults.
Scientific title
Comparing the temporal bioavailability of chondroitin sulfate sodium and derived disaccharides following a single dose of bovine or vegetarian chondroitin sulfate sodium in a crossover study with healthy adults.
Additional trial identifiers [1] 317803 0
Nil
Universal Trial Number (UTN)
U1111-1342-5479
Trial acronym
CHOICE
Related trial records

Health condition
Health condition(s) studied:
Nutrient deficiency 342718 0
Condition category
Condition code
Diet and Nutrition 338854 338854 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a two arm, randomised, double-blind, single-dose, crossover study which includes two study arms separated by a washout period of at least seven days.

At each visit, participants will consume one of the following:

A: Vegetarian chondroitin sulfate sodium (2400 mg) - taken as an oral capsule
B: Bovine chondroitin sulfate sodium (2400 mg) - taken as an oral capsule

By the end of the study, participants will have received both study interventions. Each study arm spans 48 hours. Participants must consume their intervention as quickly as possible with 200 mL of water.

Interventions will be delivered face-to-face by a research associate who has experience in participant management during clinical studies. Participants will be supervised by a member of the research team to monitor adherence.

Participants will remain on site for the initial 14 hours of each study arm. There are additional timepoints at 24, 36 and 48 hours. Participants will leave the facility after the 14-hour timepoint and will return at the 24-hour, 36-hour and 48-hour timepoints.

All visits will take place at the Bioeconomy Science Institute (BSI) clinical research facility.
Intervention code [1] 334643 0
Treatment: Other
Intervention code [2] 334870 0
Prevention
Description of the comparator or control
As participants are required to complete both study arms, they can serve as their own control.

The bovine chondroitin sulphate sodium is the comparator.
Control group
Active

Outcomes
Primary outcome [1] 346065 0
Postprandial plasma chondroitin sulfate (CS) concentrations
Timepoint [1] 346065 0
Baseline (0 hours), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours post-intervention dose (assessed for both interventions)
Secondary outcome [1] 464478 0
Compare the rate of absorption between vegetarian and bovine CS.
Timepoint [1] 464478 0
Baseline (0 hours), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours post-intervention dose (assessed for both interventions)
Secondary outcome [2] 464479 0
Compare the elimination of total plasma CS following vegetarian vs bovine CS consumption
Timepoint [2] 464479 0
Baseline (0 hours), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours post-intervention dose (assessed for both interventions)
Secondary outcome [3] 464480 0
Liver function
Timepoint [3] 464480 0
Baseline (0 hours), 8, 24, 48 hours post-intervention dose (assessed for both interventions)
Secondary outcome [4] 464481 0
Adverse effects. Examples of possible adverse effects include nausea, diarrhoea, bloating
Timepoint [4] 464481 0
Baseline (o hours), 24 and 48 hours post-intervention dose (assessed for both interventions)
Secondary outcome [5] 465048 0
Kidney function
Timepoint [5] 465048 0
Baseline (0 hours) 24 and 48 hours post-intervention dose (assessed for both interventions)

Eligibility
Key inclusion criteria
An individual of any sex, aged 18 to 55 years.

•Body mass index (BMI) within the ranges of 18 – 30 kg/m2 with bodyweight at least 50 kg
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Known allergy or hypersensitivity to chondroitin sulfate products or to any component of the study formulations (i.e. excipients including ascorbyl palmitate and rice flour).

Individuals who are pregnant or lactating.

Recent (within 3 month) surgery, hospitalisation or unresolved acute illness

Participants must not have any of the following:
-Blood borne diseases (e.g. hepatitis)
-Known hypersensitivity to fermentation-derived products or drugs or supplements
-Any history of significant disease (e.g. cardiovascular, hepatic, renal, gastrointestinal, bleeding)
-Any disease that affects drug absorption or metabolism

Screening blood results out of normal range

History of substance abuse

Smokers or vapers

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Neither the participant nor the researcher will know which intervention they will be getting for which study arm. The capsule for each intervention looks the same. A researcher not directly involved with the participant will allocate the interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Participant numbers have been set at n = 22, with a goal of 18 completing both study arms.

This sample size is typical for crossover bioavailability studies and is expected to provide sufficient power for detecting meaningful differences or demonstrating equivalence between vegetarian and bovine-derived CS.

All study data will be captured on study-specific worksheets. This can include physical/paper documents and the use of OpenClinica (a cloud-based software platform designed for clinical trials). Data may be transcribed to an access-restricted database maintained by BSI. Analysed data will be presented as mean values and standard errors of the mean. For the primary comparison of bioavailability, a standard bioequivalence analysis will be conducted. AUC and Cmax values will be log-transformed and analysed using an ANOVA model appropriate for a 2×2 crossover (including factors for subject, period, sequence, and treatment).

The geometric mean ratio (Test/Reference) for AUC (and Cmax) between vegetarian and bovine CS will be calculated, and the 90% confidence interval for the ratio will be determined. Similarly, 90% CI for the Cmax ratio may be examined as a secondary measure of bioequivalence for peak levels. Tmax will be compared using non-parametric methods (e.g., Wilcoxon signed-rank test) or descriptive statistics, since it is an ordinal measure. No formal hypothesis is set for Tmax or t1/2; those are characterized to see if there are any notable differences in absorption timing or elimination between products.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
13/11/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 28294 0
New Zealand
State/province [1] 28294 0

Funding & Sponsors
Funding source category [1] 322349 0
Commercial sector/Industry
Name [1] 322349 0
Fujian CoMo Biotechnology Co., Ltd.
Country [1] 322349 0
China
Funding source category [2] 322350 0
Commercial sector/Industry
Name [2] 322350 0
Freemen Nutra Group LLC
Country [2] 322350 0
United States of America
Funding source category [3] 322351 0
Commercial sector/Industry
Name [3] 322351 0
Zhejiang Golden-Shell Pharmaceutical Co., Ltd.
Country [3] 322351 0
China
Primary sponsor type
Other Collaborative groups
Name
Bioeconomy Science Institute
Address
Country
New Zealand
Secondary sponsor category [1] 325267 0
None
Name [1] 325267 0
Address [1] 325267 0
Country [1] 325267 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 320851 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 320851 0
Ethics committee country [1] 320851 0
New Zealand
Date submitted for ethics approval [1] 320851 0
12/08/2026
Approval date [1] 320851 0
Ethics approval number [1] 320851 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151838 0
Dr Dominic Lomiwes
Address 151838 0
Bioeconomy Science Institute, 23 Batchelar Road, Fitzherbert, Palmerston North 4410
Country 151838 0
New Zealand
Phone 151838 0
+64 06 355 6113
Fax 151838 0
Email 151838 0
[email protected]
Contact person for public queries
Name 151839 0
Dominic Lomiwes
Address 151839 0
Bioeconomy Science Institute, 23 Batchelar Road, Fitzherbert, Palmerston North 4410
Country 151839 0
New Zealand
Phone 151839 0
+64 06 355 6113
Fax 151839 0
Email 151839 0
[email protected]
Contact person for scientific queries
Name 151840 0
Dominic Lomiwes
Address 151840 0
Bioeconomy Science Institute, 23 Batchelar Road, Fitzherbert, Palmerston North 4410
Country 151840 0
New Zealand
Phone 151840 0
+64 06 355 6113
Fax 151840 0
Email 151840 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.