Effects of Peppermint Oil in Pre-metabolic Syndrome
1 other identifier
interventional
40
1 country
1
Brief Summary
Cardiovascular and metabolic diseases are leading causes of morbidity and mortality worldwide; therefore, the development of effective preventive interventions is paramount. Pre-metabolic syndrome, characterised by the presence of cardiometabolic risk factors without meeting the full diagnostic criteria for metabolic syndrome, may represent an important opportunity for early intervention. Dietary interventions are particularly attractive because they may carry fewer risks and impose a lower financial burden than pharmacological treatments. Our previous randomised trial showed that oral peppermint oil supplementation improved systolic blood pressure and selected blood lipid parameters in healthy adults. However, no placebo-controlled randomised trial has examined the effects of peppermint oil supplementation in adults with pre-metabolic syndrome. Therefore, the primary purpose of the proposed investigation is to determine whether oral peppermint oil supplementation improves cardiometabolic parameters in adults with pre-metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 6, 2026
CompletedFirst Posted
Study publicly available on registry
September 11, 2026
CompletedSeptember 11, 2026
September 1, 2026
1.6 years
September 6, 2026
September 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
Baseline
Systolic blood pressure
Systolic blood pressure - measured using a digital blood pressure monitor
20 days
Secondary Outcomes (32)
Diastolic blood pressure
Baseline
Diastolic blood pressure
20 days
Percent bodyfat and fat mass
Baseline
Percent bodyfat and fat mass
20 days
Waist circumference
Baseline
- +27 more secondary outcomes
Study Arms (2)
Peppermint oil
EXPERIMENTAL50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
Placebo
PLACEBO COMPARATORIdentical in taste and colour to the supplement juice, but with no peppermint content.
Interventions
50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.
Identical in taste and colour to the supplement juice, but with no peppermint content.
Eligibility Criteria
You may qualify if:
- Aged 18-65 years. Meet two of the five metabolic syndrome criteria. Not taking prescribed medication specifically intended to manage blood pressure, blood glucose or blood lipids.
- Able to complete written questionnaires independently. Able to provide informed consent.
You may not qualify if:
- Diagnosed diabetes mellitus. Known cardiovascular disease or clinically significant cardiovascular comorbidity, including coronary heart disease, symptomatic heart failure, clinically significant arrhythmia, or a history of stroke or transient ischaemic attack within the previous six months.
- Known or suspected secondary hypertension, including renal, renovascular or endocrine causes.
- Known clinically significant renal impairment or severe hepatic disease. Evidence or history of hypertension-related target-organ damage requiring specialist management.
- Pregnant or lactating. Allergy or known intolerance to peppermint or any ingredient contained in the intervention or placebo.
- Habitual consumption of peppermint products. Regular consumption of antioxidant or other dietary supplements likely to influence cardiometabolic outcomes.
- Body mass index greater than 40.0 kg/m². Current enrolment in another clinical trial or use of another intervention or therapy likely to influence the study outcomes.
- Any condition likely to compromise informed consent, protocol compliance or outcome assessment, including severe psychiatric illness, cognitive impairment, or active substance or alcohol misuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Lancashire
Preston, United Kingdom
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 6, 2026
First Posted
September 11, 2026
Study Start
January 1, 2025
Primary Completion
August 1, 2026
Study Completion
September 1, 2026
Last Updated
September 11, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share