Effects of Peppermint Oil in Cardiometabolic Outcomes in Participants With Metabolic Syndrome
Study Details
Study Description
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 participants with metabolic syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Identical in taste and colour to the supplement juice, but with no peppermint content. |
Other: Placebo
Placebo
|
| Experimental: Peppermint oil 50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day. |
Dietary Supplement: Peppermint oil
Peppermint oil
|
Outcome Measures
Primary Outcome Measures
- Blood pressure [Baseline]
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
- Blood pressure [20 days]
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Secondary Outcome Measures
- Percent bodyfat [Baseline]
Participants percentage composition of fat - measured using bio-electrical impedance
- Percent bodyfat [20 days]
Participants percentage composition of fat - measured using bio-electrical impedance
- Waist circumference [Baseline]
Waist circumference - measured using anthropocentric tape
- Waist circumference [20 days]
Waist circumference - measured using anthropocentric tape
- Waist to hip ratio [Baseline]
Ratio of waist to hip circumference - measured using anthropocentric tape
- 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 metabolic rate [20 days]
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
- Resting utilization of carbohydrates [Baseline]
Percent contribution of carbohydrate to daily calories - 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.
- Resting utilization of fats [20 days]
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
- Blood glucose [20 days]
Capillary blood glucose - mmol/L
- Blood triglycerides [Baseline]
Capillary blood triglycerides - mmol/L
- Blood triglycerides [20 days]
Capillary blood triglycerides - mmol/L
- Blood cholesterol (Total, HDL & LDL) [Baseline]
Capillary blood cholesterol - mmol/L
- Blood cholesterol (Total, HDL & LDL) [20 days]
Capillary blood cholesterol - mmol/L
- Capillary blood haemoglobin [Baseline]
Capillary blood haemoglobin - g/L
- Capillary blood haemoglobin [20 days]
Capillary blood haemoglobin - g/L
- Triglyceride glucose index [Baseline]
Log transformed measurement of the blood glucose and blood triglyceride measures outlined above.
- Triglyceride glucose index [20 days]
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.
- Coop-Wonka chart [20 days]
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.
- Beck Depression Inventory [20 days]
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Meet 3 of 5 criteria for Metabolic Syndrome based on National Cholesterol Education
Program-Adult Treatment Panel III guidelines:
-
Waist Circumference: >102cm (men), >88cm (women)
-
Fasting Triglycerides: ≥1.69 mmol.L-1
-
Fasting High Density Lipoprotein: <1.03 mmol.L-1 (men), <1.29 mmol.L-1 (women)
-
Blood Pressure: ≥130 mmHg SBP or ≥85 mmHg DBP
-
Fasting Glucose: ≥6.1 mmol.L-1
Exclusion Criteria:
-
Smoking current
-
Current or previous gastrointestinal, cardiovascular, hepatic or renal disease
-
Current diabetes or extreme hypertension (≥160/100 mmHg)
-
Allergy to peppermint
-
Current medication (such as steroids, NSAIDs, antibiotics, antihypertensive, hypoglycaemic, lipid-lowering drugs)
-
Currently using any nutritional supplement.
-
Heavy alcohol consumption (>14 units per week).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Central Lancashire
- Hertfordshire University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Peppermint oil METS