Pre-metabolic Syndrome
Conditions
Brief summary
Cardiovascular and metabolic diseases are leading causes of morbidity and mortality worldwide; therefore, the development of effective preventive interventions is paramount. Pre-metabolic syndrome, characterised by the presence of cardiometabolic risk factors without meeting the full diagnostic criteria for metabolic syndrome, may represent an important opportunity for early intervention. Dietary interventions are particularly attractive because they may carry fewer risks and impose a lower financial burden than pharmacological treatments. Our previous randomised trial showed that oral peppermint oil supplementation improved systolic blood pressure and selected blood lipid parameters in healthy adults. However, no placebo-controlled randomised trial has examined the effects of peppermint oil supplementation in adults with pre-metabolic syndrome. Therefore, the primary purpose of the proposed investigation is to determine whether oral peppermint oil supplementation improves cardiometabolic parameters in adults with pre-metabolic syndrome.
Interventions
DIETARY_SUPPLEMENTPeppermint Oil
50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
RADIATIONPlacebo
Identical in taste and colour to the supplement juice, but with no peppermint content.
Sponsors
University of Central Lancashire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Aged 18-65 years. Meet two of the five metabolic syndrome criteria. Not taking prescribed medication specifically intended to manage blood pressure, blood glucose or blood lipids. Able to complete written questionnaires independently. Able to provide informed consent.
Exclusion criteria
Diagnosed diabetes mellitus. Known cardiovascular disease or clinically significant cardiovascular comorbidity, including coronary heart disease, symptomatic heart failure, clinically significant arrhythmia, or a history of stroke or transient ischaemic attack within the previous six months. Known or suspected secondary hypertension, including renal, renovascular or endocrine causes. Known clinically significant renal impairment or severe hepatic disease. Evidence or history of hypertension-related target-organ damage requiring specialist management. Pregnant or lactating. Allergy or known intolerance to peppermint or any ingredient contained in the intervention or placebo. Habitual consumption of peppermint products. Regular consumption of antioxidant or other dietary supplements likely to influence cardiometabolic outcomes. Body mass index greater than 40.0 kg/m². Current enrolment in another clinical trial or use of another intervention or therapy likely to influence the study outcomes. Any condition likely to compromise informed consent, protocol compliance or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | Baseline | Systolic blood pressure - measured using a digital blood pressure monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure | Baseline | Diastolic blood pressure - measured using a digital blood pressure monitor |
| Percent bodyfat and fat mass | Baseline | Participants percentage composition of fat - measured using bio-electrical impedance |
| Waist circumference | Baseline | Waist circumference - measured using anthropocentric tape |
| Waist to hip ratio | Baseline | Ratio of waist to hip circumference - measured using anthropocentric tape |
| Blood glucose | Baseline | Capillary blood glucose - mmol/L |
| Blood triglycerides | Baseline | Capillary blood triglycerides - mmol/L |
| Blood cholesterol (Total, HDL & LDL) | Baseline | Capillary blood cholesterol - mmol/L |
| Total and HDL cholesterol ratio | Baseline | Ratio of total cholesterol to HDL cholesterol |
| LDL and HDL cholesterol ratio | Baseline | Ratio of LDL to HDL cholesterol |
| Triglyceride glucose index | Baseline | Log transformed measurement of the blood glucose and blood triglyceride measures outlined above. |
| Coop-Wonka chart | Baseline | Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing. |
| Beck Depression Inventory | Baseline | Psychological 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. |
| State Trait Anxiety Inventory | Baseline | 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 | Baseline | 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. |
| Epworth Sleepiness Scale | Baseline | 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. |
| Insomnia Severity Index | Baseline | 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. |
Countries
United Kingdom
Outcome results
None listed