NCT05561543

Brief Summary

Cardiovascular and associated hypertensive diseases are the leading health burden and cause of mortality worldwide; therefore, the necessity for effective interventions is paramount. Dietary interventions to improve cardiovascular health are highly sought after as they possess less risk and financial burden than pharmacological drugs. Our previous randomized trial has shown that oral peppermint can improving systolic blood pressure and other cardiovascular/ blood lipids in healthy individuals. However, to date, no research has explored this using a placebo randomized intervention in patients with hypertension. Therefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in participants with mild-moderate hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

September 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

September 26, 2022

Last Update Submit

January 13, 2026

Conditions

Hypertension

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)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

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

Interventions

Peppermint oilDIETARY_SUPPLEMENT

Peppermint oil

Peppermint oil
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Aged from 18-65 years
  • Systolic blood pressure 120 to 139 mmHg
  • Not taking prescribed medicine for blood pressure management
  • have the ability 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 6 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 severe hypertension related target organ damage requiring specialist management
  • pregnant or lactating women
  • allergy to peppermint
  • habitual consumption of peppermint products
  • regular consumption of antioxidant supplements
  • body mass index larger than 40.0 kg/m²
  • current enrolment in other clinical trials or use of other external therapies likely to influence outcomes
  • condition(s) 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 Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Location

Related Publications (1)

  • Sinclair J, Du X, Shadwell G, Dillon S, Butters B, Bottoms L. Effects of peppermint (Mentha piperita L.) oil in cardiometabolic outcomes in participants with pre and stage 1 hypertension: Protocol for a placebo randomized controlled trial. PLoS One. 2025 May 7;20(5):e0321986. doi: 10.1371/journal.pone.0321986. eCollection 2025.

    PMID: 40333716DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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 26, 2022

First Posted

September 30, 2022

Study Start

January 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 10, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)