None listed
Conditions
Brief summary
Glucosamine is used for the management of osteoarthritis. It shows inconsistent clinical outcomes in patients. Therefore, we propose that one possible explanation for the observed inconsistent clinical outcomes is variable inter-patient bioavailability of oral glucosamine. To test our hypothesis, we will recruit 24 healthy adult individuals, who will take two brands (Blackmores and DONA) of glucosamine supplements individually for total six days to reach a steady-state plasma concentration of glucosamine. On the sixth (last) day of dosing of each brand, we will collect their blood samples just before ingestion and then at 1, 1.5, 2, 3, 4, 5, 6, 10 and 12 hours after the ingestion of the last scheduled dose to analyse pharmacokinetic parameters at steady-state, including minimum, maximum and average plasma concentration. We will compare the obtained pharmacokinetic parameters to estimate the variation in absorption of glucosamine among the participants and across the two brands.
Interventions
Two Australian brands have chosen to be included in the present study: Blackmores Glucosamine and DONA glucosamine.
For Blackmores Glucosamine:
- the dose administered: 1500mg once-a-day
- the duration of administration: six days
- the mode of administration: an oral tablet
For DONA glucosamine:
- the dose administered: 1500mg once-a-day
- the duration of administration will be six days
- the mode of administration: soluble oral powder
Each participant will be provided with seven tablets
Two Australian brands have chosen to be included in the present study: Blackmores Glucosamine and DONA glucosamine. For Blackmores Glucosamine: - the dose administered: 1500mg once-a-day - the duration of administration: six days - the mode of administration: an oral tablet For DONA glucosamine: - the dose administered: 1500mg once-a-day - the duration of administration will be six days - the mode of administration: soluble oral powder Each participant will be provided with seven tablets of Blackmores brand in a seven-day pill/medicine-organiser box and seven sachets of DONA brand in a plastic container. At the end of the study, the participant will be asked to return the pill/medicine-organiser box and plastic container and the remaining tablets and sachets will be counted to find out if the participant has missed any dose. The participant will be asked to take glucosamine approximately at the same time for each day of the study. The participants will also be provided with a diary in which they will write the time of glucosamine ingestion for each day. The participants will return the diary at the end of the study. Each brand will be taken separately for six days with a five day washout period between the ingestion of two brands. The total duration of this study is 17 days. Blackmores brand of glucosamine will be ingested by the participants for six consecutive days (from day-1 to day-6). Washout period: The participant will not take glucosamine for the next five consecutive days (from day-7 to day-11) to undergo a washout period. This will allow for the elimination of glucosamine from the bloodstream. The DONA brand of glucosamine will be ingested by individuals from day-12 to day-17, Glucosamine is expected reach steady state plasma concentration well within five days of dosing-hence taking the blood sample for analysis on the sixth day (day-6 and day-17) of dosing.
Sponsors
Prof Gregory Peterson
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Individuals will be included if they are: a. At least 18 years of age b. Healthy individuals
Exclusion criteria
Individuals will be excluded if they are: a. Taking glucosamine supplement b. Women who are pregnant or breastfeeding c. Have shellfish allergy or allergy to glucosamine d. Suffering from any chronic medical condition/s including cancer, heart disease, asthma, diabetes and/or renal impairment e. Taking any regular medication/s
Outcome results
None listed