NCT07815899

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.6 years

First QC Date

September 6, 2026

Last Update Submit

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

EXPERIMENTAL

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

Dietary Supplement: Peppermint Oil

Placebo

PLACEBO COMPARATOR

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

Radiation: Placebo

Interventions

Peppermint OilDIETARY_SUPPLEMENT

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

Peppermint oil
PlaceboRADIATION

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

peppermint oil

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

Locations