NCT06230861

Brief Summary

Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Quercetin may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

January 19, 2024

Last Update Submit

February 25, 2026

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Systolic blood pressure

    Systolic blood pressure - measured using a digital blood pressure monitor

    Baseline

  • Systolic blood pressure

    Systolic blood pressure - measured using a digital blood pressure monitor

    20 days

Secondary Outcomes (26)

  • Diastolic blood pressure

    Baseline

  • Diastolic blood pressure

    20 days

  • Percent bodyfat

    Baseline

  • Percent bodyfat

    20 days

  • Waist to hip ratio

    Baseline

  • +21 more secondary outcomes

Study Arms (2)

Quercetin tablets 400mg 1 x p/d

EXPERIMENTAL

Quercetin tablets 400mg 1 x p/d

Dietary Supplement: Quercetin

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

QuercetinDIETARY_SUPPLEMENT

Quercetin tablets 500mg 1 x per day

Quercetin tablets 400mg 1 x p/d
PlaceboOTHER

Placebo control 1 x blinded placebo tablet per day

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Between 18 \& 65 years
  • Non-smoker
  • BMI \< 30
  • Able to give informed consent

You may not qualify if:

  • Pregnancy
  • Diabetes or any other metabolic/ uncontrolled hypertensive conditions
  • Food allergies to quercetin
  • Habitual consumption of quercetin
  • Not regularly taking medication or antioxidant supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Jonathan Sinclair, PhD, DSc

CONTACT

+447875651533jksinclair@uclan.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 30, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)