NCT05071833

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2022

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

September 28, 2021

Last Update Submit

March 28, 2023

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 (34)

  • Percent bodyfat

    Baseline

  • Percent bodyfat

    20 days

  • Waist to hip ratio

    20 days

  • Waist to hip ratio

    Baseline

  • Resting metabolic rate

    Baseline

  • +29 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 oil.DIETARY_SUPPLEMENT

Peppermint oil.

Peppermint oil
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Between 18 \& 65 years
  • Non-smoker
  • BMI \< 30
  • Able to give informed consent

You may not qualify if:

  • Pregnancy
  • Diabetes or any other metabolic/ uncontrolled hypertensive conditions
  • Food allergies to peppermint
  • Habitual consumption of peppermint
  • Not regularly taking medication or antioxidant supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonathan Sinclair

Preston, Lancashire, PR4 0PE, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 8, 2021

Study Start

November 1, 2021

Primary Completion

August 15, 2022

Study Completion

November 5, 2022

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations