None listed
Conditions
Brief summary
The aim of the study is to compare the bioavailability of animal-derived vs vegetarian chondroitin sulfate when taken as a capsule. The study will be a randomised, double-blind, single-dose, two-way crossover clinical intervention study. There will be two interventions (arms) and they will be vegetarian chondroitin sulfate sodium (2400 mg) and bovine chondroitin sulfate sodium (2400 mg), each taken in the form of a capsule. Each arm will take 48 hours to complete. Samples will be taken at designated timepoints to measure the concentration of chondroitin sulfate in blood.
Interventions
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.
Sponsors
Study design
Eligibility
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
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