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Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)

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ClinicalTrials.gov Identifier: NCT04276974
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

Brief Summary:

Previous work have shown that consumption of foods rich in polyphenols, such as berries and cocoa, led to beneficial changes in the gut microbiota composition, as well as improvements in biomarkers of cardiovascular disease risk in healthy volunteers. In addition, recent studies suggest that pesticide exposure has a detrimental effect on the gut microbiome in human populations and laboratory animals.The aim of this pilot study is to investigate the effects of short-term consumption of an organic and a non-organic plant rich diet on urinary polyphenol and pesticide levels, gut microbiome and selected biomarkers of cardiovascular health in a group of young healthy individuals.

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.


Condition or disease Intervention/treatment Phase
Healthy Men and Women Other: Organic diet Other: Non-organic diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function: the ORGAMIC Pilot Study
Estimated Study Start Date : February 24, 2020
Estimated Primary Completion Date : April 24, 2020
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: Organic first then non-organic
Organic diet then non-organic diet, each for 4 consecutive days
Other: Organic diet
Organic plant-rich foods (2000kcal for women, 2500kcal for men)

Other: Non-organic diet
Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)

Experimental: Non-organic first then organic
Non-organic diet then organic diet, each for 4 consecutive days
Other: Organic diet
Organic plant-rich foods (2000kcal for women, 2500kcal for men)

Other: Non-organic diet
Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)




Primary Outcome Measures :
  1. Changes in urinary pesticides levels [ Time Frame: Baseline & 4 days after ]
    Determine changes in urinary pesticides levels after consumption of organic plant-rich diet for 4 days measuring by chromatography coupled with mass spectrometry analytical techniques (HPLC-MS)

  2. Changes in urinary polyphenol levels [ Time Frame: Baseline & 4 days after ]
    Determine changes in urinary polyphenol profiles after consumption of organic or non-organic plant-rich diet for 4 days measuring by chromatography coupled with mass spectrometry analytical techniques (HPLC-MS)

  3. Changes in gut microbiome composition [ Time Frame: Baseline & 4 days after ]
    To determine the changes of the composition and diversity of gut microbiome (genus & species) in faecal samples collected from participants via microbiome analysis after consumption of organic or non-organic plant-rich diet for 4 days


Secondary Outcome Measures :
  1. Changes in flow-mediated-dilation (FMD) in the brachial artery [ Time Frame: Baseline & 4 days after ]
    Determine changes in flow mediated dilation (FMD) of the brachial artery using a 12 MHz ultrasound transducer (Vivid I) coupled with a sphygmomanometer cuff after consumption of organic or non-organic plant-rich diet for 4 days

  2. Changes in blood pressure [ Time Frame: Baseline & 4 days after ]
    Determine changes in systolic and diastolic blood pressure after consumption of organic or non-organic plant-rich diet for 4 days

  3. Changes in pulse wave velocity (PWV) [ Time Frame: Baseline & 4 days after ]
    Determine changes in arterial stiffness via applanation tonometry after consumption of organic or non-organic plant-rich diet for 4 days. Carotid-femoral pulse wave velocity (cfPWV) will be measured using the SphygmoCor CvMS tonometer to produce PWV readings in m/s

  4. Change in augmentation Index (AIx) [ Time Frame: Baseline & 4 days after ]
    Determine the changes on augmentation Index (AIx) using a Sphygmocor device, after consumption of organic or non-organic plant-rich diet for 4 days



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women aged 20-40 years old.
  • 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:

  • Women who are pregnant, intending to become pregnant, or breastfeeding.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276974


Contacts
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Contact: Yifan Xu +44 (0)20 7848 4162 ext 84162 yifan.xu@kcl.ac.uk
Contact: Ana Rodriguez-Mateos, PhD ana.rodriguez-mateos@kcl.ac.uk

Locations
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United Kingdom
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London Recruiting
London, United Kingdom, SE1 9NH
Contact: Yifan Xu    +44 (0)20 7848 4162 ext 84162    yifan.xu@kcl.ac.uk   
Contact: Rachel Gibson, PhD       rachel.gibson@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Ana Rodriguez-Mateos, PhD King's College London
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Responsible Party: Dr Ana Rodriguez-Mateos, Principal Investigator, Lecturer in Nutritional Sciences, King's College London
ClinicalTrials.gov Identifier: NCT04276974    
Other Study ID Numbers: HR-19/20-14
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ana Rodriguez-Mateos, King's College London:
polyphenols
pesticides
plant based food
organic
microbiome
vascular function