Cardiometabolic Syndrome
Conditions
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. Previous non-randomized interventions have shown that oral peppermint may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention. Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in healthy individuals.
Interventions
DIETARY_SUPPLEMENTPeppermint oil.
Peppermint oil.
OTHERPlacebo
Placebo
Sponsors
University of Central Lancashire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 peppermint * Habitual consumption of peppermint * Not regularly taking medication or antioxidant supplements
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 |
|---|---|---|
| Waist to hip ratio | 20 days | Ratio of waist to hip circumference - measured using anthropocentric tape |
| Resting metabolic rate | Baseline | Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry. |
| Resting utilization of carbohydrates | 20 days | Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry. |
| Resting utilization of fats | Baseline | Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry. |
| Blood glucose | Baseline | Capillary blood glucose - mmol/L |
| Triglyceride glucose index | Baseline | Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2) |
| Blood triglycerides | Baseline | Capillary blood triglycerides - mmol/L |
| Blood cholesterol (Total, HDL & LDL) | Baseline | Capillary blood cholesterol - mmol/L |
| Percent bodyfat | Baseline | Participants percentage composition of fat - measured using bio-electrical impedance |
| 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. |
| 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. |
| 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. |
| Diastolic blood pressure | Baseline | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor |
| Blood haemoglobin | Baseline | Capillary blood haemoglobin - g/L |
Countries
United Kingdom
Outcome results
None listed