Plasma-Induced Changes in the Metabolome Following Polyphenol Consumption

NCT06144489 | Completed

• 1 other identifier: 89012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Processes, Metabolic

Outcome Measures

Primary Outcomes (1)

• Processes, Metabolic

  Using untargeted plasma analysis, metabolite characterisations are performed on a LCMS.

  up to 8 hours

Study Arms (3)

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.

Dietary Supplement: Tart Cherry

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.

Dietary Supplement: Tart Cherry

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Tart Cherry DIETARY_SUPPLEMENT

Tart cherry supplementation in two doses

Also known as: European

High Dose; Low Dose

Placebo DIETARY_SUPPLEMENT

Control group

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• fit and healthy, and not currently taking any prescription medication, anti-inflammatory, anti-oxidant supplementation in the last 3 months

You may not qualify if:

• history of gastrointestinal, renal and/or cardiovascular disease, as well as any thyroid issues.
• smoker
• allergies
• needle/blood phobia

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Study Officials

• Glyn Howatson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Glyn Howatson

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: March 31, 2022
• Primary Completion: June 30, 2022
• Study Completion: April 25, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)