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

NCT04276974 | Completed

• 1 other identifier: HR-19/20-14
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Men and Women

Keywords

polyphenols; pesticides; plant based food; organic; microbiome; vascular function

Outcome Measures

Primary Outcomes (3)

• Changes in urinary pesticides levels

  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)

  Baseline & 4 days after

• Changes in urinary polyphenol levels

  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)

  Baseline & 4 days after

• Changes in gut microbiome composition

  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

  Baseline & 4 days after

Secondary Outcomes (4)

• Changes in flow-mediated-dilation (FMD) in the brachial artery

  Baseline & 4 days after

• Changes in blood pressure

  Baseline & 4 days after

• Changes in pulse wave velocity (PWV)

  Baseline & 4 days after

• Change in augmentation Index (AIx)

  Baseline & 4 days after

Study Arms (2)

Organic first then non-organic

EXPERIMENTAL

Organic diet then non-organic diet, each for 4 consecutive days

Other: Organic diet; Other: Non-organic diet

Non-organic first then organic

EXPERIMENTAL

Non-organic diet then organic diet, each for 4 consecutive days

Other: Organic diet; Other: Non-organic diet

Interventions

Organic diet OTHER

Organic plant-rich foods (2000kcal for women, 2500kcal for men)

Non-organic first then organic; Organic first then non-organic

Non-organic diet OTHER

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

Non-organic first then organic; Organic first then non-organic

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London

London, SE1 9NH, United Kingdom

Location

Study Officials

• Ana Rodriguez-Mateos, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Lecturer in Nutritional Sciences

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: February 24, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)