NCT06795438

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 Green tea may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.

Trial Health

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Monitor

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
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress51%
Apr 2025Jun 2027

First Submitted

Initial submission to the registry

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

January 21, 2025

Last Update Submit

March 24, 2025

Conditions

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)

Green tea

EXPERIMENTAL

Green tea tablets 1000mg 1 x per day

Dietary Supplement: Green tea

Placebo

PLACEBO COMPARATOR

Placebo control 1 x blinded placebo tablet per day

Other: Placebo

Interventions

Green teaDIETARY_SUPPLEMENT

Green tea tablets 1000mg 1 x per day

Green tea
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

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Tea

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Jonathan Sinclair, PhD, DSc

CONTACT

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 21, 2025

First Posted

January 28, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations