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Effects of Peppermint Oil in Cardiometabolic Outcomes

Primary Purpose

Cardiometabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Peppermint oil.
Placebo
Sponsored by
University of Central Lancashire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiometabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jonathan Sinclair

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Peppermint oil

Arm Description

Identical in taste and colour to the supplement juice, but with no peppermint content.

50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.

Outcomes

Primary Outcome Measures

Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor

Secondary Outcome Measures

Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Percent bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Resting metabolic rate
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting metabolic rate
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fats
Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fats
Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Blood glucose
Capillary blood glucose - mmol/L
Blood glucose
Capillary blood glucose - mmol/L
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Triglyceride glucose index
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Blood triglycerides
Capillary blood triglycerides - mmol/L
Blood triglycerides
Capillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Blood haemoglobin
Capillary blood haemoglobin - g/L
Blood haemoglobin
Capillary blood haemoglobin - g/L
Coop-Wonka chart
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
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.
Coop-Wonka chart
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
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
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
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
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
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
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
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
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
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
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Diastolic blood pressure
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor

Full Information

First Posted
September 28, 2021
Last Updated
March 28, 2023
Sponsor
University of Central Lancashire
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1. Study Identification

Unique Protocol Identification Number
NCT05071833
Brief Title
Effects of Peppermint Oil in Cardiometabolic Outcomes
Official Title
Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
November 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 healthy individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical in taste and colour to the supplement juice, but with no peppermint content.
Arm Title
Peppermint oil
Arm Type
Experimental
Arm Description
50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Peppermint oil.
Intervention Description
Peppermint oil.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure - measured using a digital blood pressure monitor
Time Frame
Baseline
Title
Systolic blood pressure
Description
Systolic blood pressure - measured using a digital blood pressure monitor
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Percent bodyfat
Description
Participants percentage composition of fat - measured using bio-electrical impedance
Time Frame
Baseline
Title
Percent bodyfat
Description
Participants percentage composition of fat - measured using bio-electrical impedance
Time Frame
20 days
Title
Waist to hip ratio
Description
Ratio of waist to hip circumference - measured using anthropocentric tape
Time Frame
20 days
Title
Waist to hip ratio
Description
Ratio of waist to hip circumference - measured using anthropocentric tape
Time Frame
Baseline
Title
Resting metabolic rate
Description
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Resting metabolic rate
Description
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Resting utilization of carbohydrates
Description
Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Resting utilization of carbohydrates
Description
Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Resting utilization of fats
Description
Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Resting utilization of fats
Description
Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Blood glucose
Description
Capillary blood glucose - mmol/L
Time Frame
Baseline
Title
Blood glucose
Description
Capillary blood glucose - mmol/L
Time Frame
20 days
Title
Triglyceride glucose index
Description
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time Frame
Baseline
Title
Triglyceride glucose index
Description
Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)
Time Frame
20 days
Title
Blood triglycerides
Description
Capillary blood triglycerides - mmol/L
Time Frame
Baseline
Title
Blood triglycerides
Description
Capillary blood triglycerides - mmol/L
Time Frame
20 days
Title
Blood cholesterol (Total, HDL & LDL)
Description
Capillary blood cholesterol - mmol/L
Time Frame
Baseline
Title
Blood cholesterol (Total, HDL & LDL)
Description
Capillary blood cholesterol - mmol/L
Time Frame
20 days
Title
Blood haemoglobin
Description
Capillary blood haemoglobin - g/L
Time Frame
Baseline
Title
Blood haemoglobin
Description
Capillary blood haemoglobin - g/L
Time Frame
20 days
Title
Coop-Wonka chart
Description
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.
Time Frame
Baseline
Title
Beck Depression Inventory
Description
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.
Time Frame
Baseline
Title
Coop-Wonka chart
Description
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.
Time Frame
20 days
Title
Beck Depression Inventory
Description
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.
Time Frame
20 days
Title
State Trait Anxiety Inventory
Description
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.
Time Frame
Baseline
Title
State Trait Anxiety Inventory
Description
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.
Time Frame
20 days
Title
Insomnia Severity Index
Description
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.
Time Frame
20 days
Title
Insomnia Severity Index
Description
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.
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
20 days
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
Baseline
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
20 days
Title
Diastolic blood pressure
Description
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Time Frame
Baseline
Title
Diastolic blood pressure
Description
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Jonathan Sinclair
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR4 0PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Peppermint Oil in Cardiometabolic Outcomes

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