Effects of Peppermint Oil in Cardiometabolic Outcomes

Not Applicable

Completed

• Conditions: Cardiometabolic Syndrome
• Interventions: Dietary Supplement: Peppermint oil.; Other: Placebo

• Registration Number: NCT05071833
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-08
• Study Start: 2021-11-01
• Primary Completion: 2022-08-15
• Study Completion: 2022-11-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peppermint oil	Peppermint oil.	50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
Placebo	Placebo	Identical in taste and colour to the supplement juice, but with no peppermint content.

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
Waist to hip ratio	Baseline	Ratio of waist to hip circumference - measured using anthropocentric tape
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 fats	20 days	Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Blood glucose	20 days	Capillary blood glucose - mmol/L
Triglyceride glucose index	20 days	Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Blood triglycerides	20 days	Capillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)	20 days	Capillary blood cholesterol - mmol/L
Blood haemoglobin	20 days	Capillary blood haemoglobin - g/L
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	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	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.
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	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.
Diastolic blood pressure	20 days	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor

Trial Locations

Locations (1)

Jonathan Sinclair; 🇬🇧 Preston, Lancashire, United Kingdom