Clinical trial NCT05071833: Effects of Peppermint Oil in Cardiometabolic Outcomes
Official title: Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 20 days
Secondary outcomes:
measure: Percent bodyfat
timeFrame: Baseline
measure: Percent bodyfat
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: Baseline
measure: Resting metabolic rate
timeFrame: Baseline
measure: Resting metabolic rate
timeFrame: 20 days
measure: Resting utilization of carbohydrates
timeFrame: 20 days
measure: Resting utilization of carbohydrates
timeFrame: Baseline
measure: Resting utilization of fats
timeFrame: Baseline
measure: Resting utilization of fats
timeFrame: 20 days
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 20 days
measure: Triglyceride glucose index
timeFrame: Baseline
measure: Triglyceride glucose index
timeFrame: 20 days
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 20 days
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: Baseline
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: 20 days
measure: Blood haemoglobin
timeFrame: Baseline
measure: Blood haemoglobin
timeFrame: 20 days
measure: Coop-Wonka chart
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Coop-Wonka chart
timeFrame: 20 days
measure: Beck Depression Inventory
timeFrame: 20 days
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 20 days
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: 20 days
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Jonathan Sinclair
state: Lancashire
Study officials:
References: