Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-05 @ 3:39 PM
Study NCT ID:
NCT05071833
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Peppermint Oil in Cardiometabolic Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015424', 'term': 'peppermint oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'Baseline', 'description': 'Systolic blood pressure - measured using a digital blood pressure monitor'}, {'measure': 'Systolic blood pressure', 'timeFrame': '20 days', 'description': 'Systolic blood pressure - measured using a digital blood pressure monitor'}], 'secondaryOutcomes': [{'measure': 'Percent bodyfat', 'timeFrame': 'Baseline', 'description': 'Participants percentage composition of fat - measured using bio-electrical impedance'}, {'measure': 'Percent bodyfat', 'timeFrame': '20 days', 'description': 'Participants percentage composition of fat - measured using bio-electrical impedance'}, {'measure': 'Waist to hip ratio', 'timeFrame': '20 days', 'description': 'Ratio of waist to hip circumference - measured using anthropocentric tape'}, {'measure': 'Waist to hip ratio', 'timeFrame': 'Baseline', 'description': 'Ratio of waist to hip circumference - measured using anthropocentric tape'}, {'measure': 'Resting metabolic rate', 'timeFrame': 'Baseline', 'description': 'Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.'}, {'measure': 'Resting metabolic rate', 'timeFrame': '20 days', 'description': 'Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.'}, {'measure': 'Resting utilization of carbohydrates', 'timeFrame': '20 days', 'description': 'Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.'}, {'measure': 'Resting utilization of carbohydrates', 'timeFrame': 'Baseline', 'description': 'Percent contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.'}, {'measure': 'Resting utilization of fats', 'timeFrame': 'Baseline', 'description': 'Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.'}, {'measure': 'Resting utilization of fats', 'timeFrame': '20 days', 'description': 'Percent contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.'}, {'measure': 'Blood glucose', 'timeFrame': 'Baseline', 'description': 'Capillary blood glucose - mmol/L'}, {'measure': 'Blood glucose', 'timeFrame': '20 days', 'description': 'Capillary blood glucose - mmol/L'}, {'measure': 'Triglyceride glucose index', 'timeFrame': 'Baseline', 'description': 'Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)'}, {'measure': 'Triglyceride glucose index', 'timeFrame': '20 days', 'description': 'Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)'}, {'measure': 'Blood triglycerides', 'timeFrame': 'Baseline', 'description': 'Capillary blood triglycerides - mmol/L'}, {'measure': 'Blood triglycerides', 'timeFrame': '20 days', 'description': 'Capillary blood triglycerides - mmol/L'}, {'measure': 'Blood cholesterol (Total, HDL & LDL)', 'timeFrame': 'Baseline', 'description': 'Capillary blood cholesterol - mmol/L'}, {'measure': 'Blood cholesterol (Total, HDL & LDL)', 'timeFrame': '20 days', 'description': 'Capillary blood cholesterol - mmol/L'}, {'measure': 'Blood haemoglobin', 'timeFrame': 'Baseline', 'description': 'Capillary blood haemoglobin - g/L'}, {'measure': 'Blood haemoglobin', 'timeFrame': '20 days', 'description': 'Capillary blood haemoglobin - g/L'}, {'measure': 'Coop-Wonka chart', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.'}, {'measure': 'Coop-Wonka chart', 'timeFrame': '20 days', 'description': 'Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '20 days', 'description': 'Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': '20 days', 'description': 'Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '20 days', 'description': 'Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Baseline', 'description': 'Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline', 'description': 'Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '20 days', 'description': 'Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'Baseline', 'description': 'Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '20 days', 'description': 'Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Baseline', 'description': 'Systolic and diastolic blood pressure - measured using a digital blood pressure monitor'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '20 days', 'description': 'Systolic and diastolic blood pressure - measured using a digital blood pressure monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiometabolic Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nTherefore, the primary purpose of the proposed investigation is to test the ability of oral peppermint oil supplementation to improve cardiometabolic parameters in healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Between 18 \\& 65 years\n* Non-smoker\n* BMI \\< 30\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes or any other metabolic/ uncontrolled hypertensive conditions\n* Food allergies to peppermint\n* Habitual consumption of peppermint\n* Not regularly taking medication or antioxidant supplements'}, 'identificationModule': {'nctId': 'NCT05071833', 'briefTitle': 'Effects of Peppermint Oil in Cardiometabolic Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Lancashire'}, 'officialTitle': 'Effects of Oral Peppermint Supplementation on Cardiometabolic Parameters', 'orgStudyIdInfo': {'id': 'Peppermint oil cardiometabolic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical in taste and colour to the supplement juice, but with no peppermint content.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Peppermint oil', 'description': '50 uL of peppermint oil, which will be diluted with 100 mL of water - taken twice per day.', 'interventionNames': ['Dietary Supplement: Peppermint oil.']}], 'interventions': [{'name': 'Peppermint oil.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Peppermint oil.', 'armGroupLabels': ['Peppermint oil']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PR4 0PE', 'city': 'Preston', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Jonathan Sinclair', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Lancashire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan Sinclair', 'investigatorAffiliation': 'University of Central Lancashire'}}}}