Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)
NCT ID: NCT04276974
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2020-02-24
2021-07-17
Brief Summary
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Healthy men and women participants (10) will be recruited for a 2-arm randomised crossover controlled trial. Urinary polyphenol and pesticide levels after consumption of an organic and non-organic plant rich diet for 4 days will be analysed. Changes in gut microbiome composition and biomarkers of cardiovascular disease risk (flow-mediated dilation, blood pressure and arterial stiffness) will also be investigated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Organic first then non-organic
Organic diet then non-organic diet, each for 4 consecutive days
Organic diet
Organic plant-rich foods (2000kcal for women, 2500kcal for men)
Non-organic diet
Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)
Non-organic first then organic
Non-organic diet then organic diet, each for 4 consecutive days
Organic diet
Organic plant-rich foods (2000kcal for women, 2500kcal for men)
Non-organic diet
Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)
Interventions
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Organic diet
Organic plant-rich foods (2000kcal for women, 2500kcal for men)
Non-organic diet
Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 18.5 and 30 kg/m2.
* Non-smokers
* Not already participating in a clinical trial.
* No diagnosed heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.
* Not currently taking any medication
* No history of excess alcohol intake or substance abuse.
* Happy to follow dietary instructions before and during the study and to attend the research centre for breakfast and lunch for a total of 10 days.
* Ability to prepare basic meals from ingredients provided.
* No food intolerances, allergies, hypersensitivity or follow any dietary restriction (e.g. gluten intolerance, coeliac, lactose intolerance) that will prevent your ability to follow the test diets.
* Weight stable (no weight change by more than 3 kg in the last 2 months).
* No travel arrangements outside the United Kingdom (UK) within the period of data collection.
* Able to understand the information sheet and willing to comply with study protocol.
* Able to give informed written consent.
Exclusion Criteria
* Participation in another clinical trial - Unable to comply with the study protocol.
* Weight change \>3kg in preceding 2 months and body mass index \<18.5 or \>30 kg/m2
* Current smokers, or reported giving up smoking within the last 6 months History of substance abuse, previous or current high alcohol intake (\>28 units/week for males and \>21 units/week for females).
* Reported history of Cardiovascular disease, diabetes, cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function)
* Blood pressure ≥160/100 mmHg
* Travel arrangements outside UK within the period of data collection.
20 Years
40 Years
ALL
Yes
Sponsors
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King's College London
OTHER
Responsible Party
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Dr Ana Rodriguez-Mateos
Principal Investigator, Lecturer in Nutritional Sciences
Principal Investigators
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Ana Rodriguez-Mateos, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
London, , United Kingdom
Countries
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Other Identifiers
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HR-19/20-14
Identifier Type: -
Identifier Source: org_study_id
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