Plasma-Induced Changes in the Metabolome Following Polyphenol Consumption
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northumbria University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Processes, Metabolic
Study Overview
Brief Summary
The goal of this clinical trial is to compare the changes in the human metabolome following a low or high acute dose of European tart cherries. The main question it aims to answer is:
what effect do European tart cherries have on the human metabolome?
Participants will attend the laboratory at the university on 3 separate occasions. Take a 3 different supplements: a placebo, low or high dose of European tart cherry supplement. Have venous blood samples taken as baseline, then 1, 2, 3, 5 and 8 h post ingestion of the supplement. Researchers will compare placebo, low and high to see if changes the human metabolome.
Detailed Description
Participants Twelve healthy participants (nine male and three female) were recruited for this study; the mean ± SD age, stature, mass and body mass index (BMI) were 29 ± 7 years old, 174.8 ± 9.3 cm, 77.29 ± 10.52 kg and 25.23 ± 1.87 kg/m2, respectively. All participants were healthy, as assessed by a health-screening questionnaire and provided written, informed consent. Exclusion criteria for the study were as follows: food allergy (as discussed with research team), history of gastrointestinal, renal, cardiovascular or thyroid disease and current use of any food supplementations. This study received ethical approval from Northumbria University Ethics Committee (reference number: 39904) (clinical trial tbc).
Experimental Design The study utilised a double blind, three-arm cross-over, pseudo-randomised (counter-balanced to eliminate order effects) design in order to identify metabolomic shifts following the acute ingestion of a low dose (LOW), high dose (HI) of TC or placebo (CON). A washout period of at least 7 days (but not greater than 21 days) between each phase was implemented. Participants were required to attend the start of each phase of the study at 7:45 am following a 10 h overnight fast in order to account for diurnal variation (Figure 1). Upon arrival to the lab, the participants baseline blood pressure (BP) was recorded in a rested state (following at least 5 mins of sitting), then cannulated for serial blood sampling. A standardized breakfast was then provided. Subsequent measures were then taken at baseline, 1, 2, 3, 5 and 8 hrs post-VTC consumption. Water was provided ad-libitum, but no additional food was given during testing visits.
Treatments and Dietary Control The low (LOW) and high (HI) dose consisted of 3 or 6 g of the TC supplement (CherryCraft), respectively, or a 3g capsule placebo (CON) matched for caloric content using maltodextrin. The low TC dose provided approximately 60-78 mg of anthocyanins, 8.07 kcal and had a macronutrient content of 1.215 g, 0.003 g, 0.042 g, for carbohydrates, fat and protein, respectively. The high TC dose provided approximately 120-156 mg of anthocyanins, 16.14 kcal with 2.43 g, 0.006 g, 0.08 g for carbohydrates, fat and protein, respectively.
Participants were requested to follow their habitual diet throughout the trial. Food diaries were completed for the 24 hrs before each testing visit to replicate (as close to) prior to testing on following testing visits. The standardized breakfast consisted of white toast (2 slices of Sainsbury's medium white bread) and butter (approx. 16g of Bertolli/Vitalite (a vegan alternative, matched as closely as possible for calories and macronutrient content)). Participants were given water to drink ad-libitum throughout the testing visits, this was measured and refilled from baseline, and 1, 2, 3, 5 and 8 hrs post breakfast and supplement ingestion.
Blood Pressure Monitoring Blood pressure was monitored throughout the testing visits, immediately upon arrival to the lab and, 1, 2, 3, 5 and 8 hrs following ingestion of the supplement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •fit and healthy, and not currently taking any prescription medication, anti-inflammatory, anti-oxidant supplementation in the last 3 months
Exclusion Criteria
- •history of gastrointestinal, renal and/or cardiovascular disease, as well as any thyroid issues.
- •allergies
- •needle/blood phobia
Arms & Interventions
Placebo
Matched with the active low dose, this placebo was matched for calorific content.
Intervention: Placebo (Dietary Supplement)
High Dose
High dose (6g) of Vistula tart cherry, freeze dried. 120-156 mg of anthocyanins, 16.14 kcal with 2.43 g, 0.006 g, 0.08 g for carbohydrates, fat and protein, respectively.
Intervention: Tart Cherry (Dietary Supplement)
Low Dose
Low dose (3g) of Vistula tart cherry, freeze dried. 60-78 mg of anthocyanins, 8.07 kcal and had a macronutrient content of 1.215 g, 0.003 g, 0.042 g, for carbohydrates, fat and protein, respectively.
Intervention: Tart Cherry (Dietary Supplement)
Outcomes
Primary Outcomes
Processes, Metabolic
Time Frame: up to 8 hours
Using untargeted plasma analysis, metabolite characterisations are performed on a LCMS.
Secondary Outcomes
No secondary outcomes reported
Investigators
Glyn Howatson
Professor Glyn Howatson
Northumbria University
