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Clinical Trials/NCT06144489
NCT06144489CompletedNot Applicable

Plasma-Induced Changes in the Metabolome Following Polyphenol Consumption

Northumbria University1 site in 1 country12 target enrollmentStarted: March 31, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Placebo Comparator

Matched with the active low dose, this placebo was matched for calorific content.

Intervention: Placebo (Dietary Supplement)

High Dose

Active Comparator

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

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Glyn Howatson

Professor Glyn Howatson

Northumbria University

Study Sites (1)

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