None listed
Conditions
Brief summary
The aim of the study is to determine how targeted sarmentosin metabolites from blackcurrants are absorbed, metabolised and excreted by the body. The study will be a randomised, double-blinded, crossover intervention study. There will be two arms, each spanning 48 hours. The intervention and the placebo will be taken in the form of a 250 mL drink. Samples will be taken at designated timepoints to measure the appearance of sarmentosin metabolites in blood, urine and faeces.
Interventions
There are two components to this study. The first is a Pilot study, which will be used to identify sarmentosin metabolites that will be targeted in the main dietary intervention study. The Pilot study will also be used to determine the number of participants required for the Dietary intervention study. PILOT STUDY There is only one arm, which spans 48 hours. The intervention is a blackcurrant extract providing 100 mg of sarmentosin dissolved in 250 mL of water. The intervention will be delivered face-to-face by a research associate who has many years 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 four hours of the study arm, There are additional timepoints at 8, 12, 24 and 48 hours. Participants may leave the facility after the 4-hour timepoint but must ensure that they return well before each subsequent sampling time. All visits will take place at the Bioeconomy Science Institute's clinical facility. DIETARY INTERVENTION STUDY As no comprehensive pharmacokinetic data are available for blackcurrant-derived (BC-derived) sarmentosin and its metabolites, a reliable a priori sample size calculation is not possible. Accordingly, this study incorporates an adaptive design in which the sample size for the main Dietary Intervention Study will be estimated using data obtained from the initial Pilot Study. Specifically, results from the Pilot Study on the appearance and clearance of sarmentosin and its metabolites in plasma from at least five participants (n = 5) will be used to estimate inter-individual variability. These data will then be used to determine the sample size required for the Dietary Intervention Study, targeting an inter-individual coefficient of variation of =20% for key pharmacokinetic parameters. This is a two arm, randomised crossover study which includes two study arms separated by a washout period of at least five days. For one of the study arms, participants will consume the following intervention. Intervention 2 - a blackcurrant extract providing 100 mg of sarmentosin dissolved in 250 mL of water. By the end of the study, participants will have received both study interventions. Each study arm spans 48 hours. Participants are expected to consume their intervention as soon as possible. The intervention will be delivered face-to-face by a research associate who has many years 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 4 hours of the study arm, There are additional timepoints at 8, 12, 24 and 48 hours. Participants may leave the facility after the 4-hour timepoint but must ensure that they return well before each subsequent sampling time. All visits will take place at the Bioeconomy Science Institute's clinical facility.
Sponsors
Study design
Eligibility
Inclusion criteria
An individual of any sex aged 18 - 50 years
Exclusion criteria
They will also be excluded if they are allergic to, or intolerant of, blackcurrants or blackcurrant-derived foods. In addition, volunteers will be excluded if they are pregnant, planning to get pregnant in the near future or are breast feeding. They must not have any of the following: (i) blood-borne diseases (e.g. hepatitis), (ii) recent bacterial or viral illness, (iii) are taking medication that affects the properties of blood (e.g. blood clotting), (iv) have a strong fear or dislike of needles and/or the sight of blood, or have veins that are difficult to access, (v) have a chronic illness (e.g. cancer), (vi) are taking medication for weight loss (e.g. Wegovy, Ozempic, Saxenda), (vii) are taking medication for mental health or mood disorders, (viii) donated blood to the blood bank within four weeks of starting the study. Volunteers who smoke or vape are ineligible to take part.