Effects of Green Tea on Cardiometabolic Outcomes

Not Applicable

Not yet recruiting

• Conditions: Cardiometabolic Syndrome

• Registration Number: NCT06795438
• Lead Sponsor: University of Central Lancashire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Study Start: 2025-04-01
• Primary Completion: 2027-02-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	20 days	Systolic blood pressure - measured using a digital blood pressure monitor

Secondary Outcome Measures

Name	Time	Method
Percent bodyfat	20 days	Participants percentage composition of fat - measured using bio-electrical impedance
Diastolic blood pressure	20 days	Diastolic blood pressure - measured using a digital blood pressure monitor
Blood triglycerides	20 days	Capillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)	20 days	Capillary blood cholesterol - mmol/L
Beck Depression Inventory	20 days	sychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Epworth Sleepiness Scale	20 days	Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Waist to hip ratio	20 days	Ratio of waist to hip circumference - measured using anthropocentric tape
Blood glucose	20 days	Capillary blood glucose - mmol/L
Insomnia Severity Index	20 days	Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Triglyceride glucose index	20 days	Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Coop-Wonka chart	20 days	Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
State Trait Anxiety Inventory	20 days	Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Pittsburgh Sleep Quality Index	20 days	Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.

Trial Locations

Locations (1)

University of Central Lancashire; 🇬🇧 Preston, Lancashire, United Kingdom