Cardiometabolic SyndromeNCT06795438
Effects of Green Tea on Cardiometabolic Outcomes
A study testing Green tea in people with Cardiometabolic Syndrome, run by University of Central Lancashire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- Green tea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2025to 1 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Between 18 \& 65 years
- Non-smoker
- BMI < 30
- Able to give informed consent
Who cannot join
- Pregnancy
- Diabetes or any other metabolic/ uncontrolled hypertensive conditions
- Food allergies to quercetin
- Habitual consumption of quercetin
- Not regularly taking medication or antioxidant supplements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Central Lancashire
Preston, Lancashire, PR4 0PE
Jonathan Sinclair, DSc, PhD, 07875651533, jksinclair@uclan.ac.uk
About this study
Official title: Effects of Green Tea Supplementation on Cardiometabolic Parameters
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.
- Conditions
- Cardiometabolic Syndrome
- Being tested
- Green tea, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green teaDietary supplement
Green tea tablets 1000mg 1 x per day
PlaceboOther
Placebo control 1 x blinded placebo tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Green tea | Experimental | Green tea tablets 1000mg 1 x per day Receives: Dietary Supplement: Green tea |
| Placebo | Placebo comparator | Placebo control 1 x blinded placebo tablet per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Measured: 20 days
Secondary outcomes (26)
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Measured: Baseline
Diastolic blood pressure
Diastolic blood pressure - measured using a digital blood pressure monitor
Measured: 20 days
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: Baseline
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Measured: 20 days
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: Baseline
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Measured: 20 days
Blood glucose
Capillary blood glucose - mmol/L
Measured: Baseline
Blood glucose
Capillary blood glucose - mmol/L
Measured: 20 days
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: Baseline
Blood triglycerides
Capillary blood triglycerides - mmol/L
Measured: 20 days
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Measured: Baseline
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Measured: 20 days
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Measured: Baseline
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Measured: 20 days
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Measured: Baseline
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring
Measured: 20 days
Beck Depression Inventory
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.
Measured: Baseline
Beck Depression Inventory
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.
Measured: 20 days
State Trait Anxiety Inventory
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.
Measured: Baseline
State Trait Anxiety Inventory
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.
Measured: 20 days
Insomnia Severity Index
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.
Measured: Baseline
Insomnia Severity Index
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.
Measured: 20 days
Pittsburgh Sleep Quality Index
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.
Measured: Baseline
Pittsburgh Sleep Quality Index
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.
Measured: 20 days
Epworth Sleepiness Scale
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.
Measured: Baseline
Epworth Sleepiness Scale
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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795438
- Sponsor's protocol ID
- Green tea cardiometabolic
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No