None listed
Conditions
Brief summary
The study aims to determine the effect of an apple extract prototype product on suppressing the glycaemic response. This is a four-arm, randomised, crossover, placebo-controlled study involving 20 healthy adult volunteers (25-75 years) who have been recruited from the general population. Participants will be required to complete all four arms, with each arm separated by a washout period of at least three full days. Participants will receive a dose of either maltodextrin or sucrose (carbohydrate challenge), with and without apple extract, and their postprandial glycaemic response will be monitored for two hours by measuring glucose in finger-prick capillary blood samples. Participants will receive the following study interventions in a randomised order: Intervention 1: 100 mL water + placebo (2 capsules) + 50g maltodextrin in 250mL water Intervention 2: 100 mL water + apple extract (2 capsules) + 50 g maltodextrin in 250mL water Intervention 3: 100 mL water + apple extract (2 capsules) + 75 g sucrose in 250mL water Intervention 4: 100 mL water + placebo (2 capsules) + 75g sucrose in 250mL water
Interventions
This is a four-arm, randomised, crossover, placebo-controlled study which includes four study days separated by a washout period of at least 72 hours.
The two study interventions are:
Arm 2: 100 mL water + apple extract (2 capsules each containing 0.5 g of extract) + 50 g maltodextrin (carbohydrate challenge) in 250mL water
Arm 3: 100 mL water + apple extract (2 capsules each containing 0.5 g of extract) + 75 g sucrose (carbohydrate challenge) in 250mL water
Study visits will take approxim
This is a four-arm, randomised, crossover, placebo-controlled study which includes four study days separated by a washout period of at least 72 hours. The two study interventions are: Arm 2: 100 mL water + apple extract (2 capsules each containing 0.5 g of extract) + 50 g maltodextrin (carbohydrate challenge) in 250mL water Arm 3: 100 mL water + apple extract (2 capsules each containing 0.5 g of extract) + 75 g sucrose (carbohydrate challenge) in 250mL water Study visits will take approximately 2.5 hours and a participant will be in the study for about 1-2 months. By the end of the study, participants would have completed all four study arms. Participants must consume their intervention as quickly as possible. The interventions will be delivered to participant in the Human Clinical Research Facility, face-to-face, by a member of the research team, who will supervise the participant to monitor adherence. The participant-facing members of the research team each have 10 plus years of experience managing clinical studies.
Sponsors
Bioeconomy Science Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
An individual of any sex, aged 25 - 75 years of age. Participants must have a Body Mass Index (BMI) of 25.0-34.9 kg/m2, and a fasting blood glucose level of less than 6.1 mmol/L.
Exclusion criteria
Volunteers will be excluded if they are unwilling or unable to comply with the study procedures. Volunteers cannot take part if they are taking part in another study at the same time. They will also be excluded if they are allergic to (or intolerant of) apple or the constituents of the placebo capsule. 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 (v) have a chronic illness (e.g. cancer), (vi) are taking medication for weight loss (e.g. Wegovy, Ozempic, Saxenda) or medications that affect blood sugar (e.g. diabetic medications), (vii) smoke or vape, (viii) any gastrointestinal disorders (e.g. IBS, IBD).
Outcome results
None listed