Clinical trial NCT04276974: Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)
Official title: Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function: the ORGAMIC Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men and Women
Keywords: polyphenols
pesticides
plant based food
organic
microbiome
vascular function
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Changes in urinary pesticides levels
timeFrame: Baseline & 4 days after
measure: Changes in urinary polyphenol levels
timeFrame: Baseline & 4 days after
measure: Changes in gut microbiome composition
timeFrame: Baseline & 4 days after
Secondary outcomes:
measure: Changes in flow-mediated-dilation (FMD) in the brachial artery
timeFrame: Baseline & 4 days after
measure: Changes in blood pressure
timeFrame: Baseline & 4 days after
measure: Changes in pulse wave velocity (PWV)
timeFrame: Baseline & 4 days after
measure: Change in augmentation Index (AIx)
timeFrame: Baseline & 4 days after
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
Study officials:
affiliation: King's College London
name: Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
References: