Healthy Men and WomenNCT04276974
Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)
A study testing Organic diet and Non-organic diet in people with Healthy Men and Women, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- Organic diet and Non-organic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2020to 17 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
London, SE1 9NH
About this study
Official title: Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function: the ORGAMIC Pilot Study
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
- Being tested
- Organic diet, Non-organic diet
- Keywords
- polyphenols, pesticides, plant based food, organic, microbiome, vascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic dietOther
Organic plant-rich foods (2000kcal for women, 2500kcal for men)
Non-organic dietOther
Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)
| Study group | Role | What they receive |
|---|---|---|
| Organic first then non-organic | Experimental | Organic diet then non-organic diet, each for 4 consecutive days Receives: Other: Organic diet; Other: Non-organic diet |
| Non-organic first then organic | Experimental | Non-organic diet then organic diet, each for 4 consecutive days Receives: Other: Organic diet; Other: Non-organic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: Baseline & 4 days after
Secondary outcomes (4)
Changes in flow-mediated-dilation (FMD) in the brachial artery
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
Measured: Baseline & 4 days after
Changes in blood pressure
Determine changes in systolic and diastolic blood pressure after consumption of organic or non-organic plant-rich diet for 4 days
Measured: Baseline & 4 days after
Changes in pulse wave velocity (PWV)
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
Measured: Baseline & 4 days after
Change in augmentation Index (AIx)
Determine the changes on augmentation Index (AIx) using a Sphygmocor device, after consumption of organic or non-organic plant-rich diet for 4 days
Measured: Baseline & 4 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start24 Feb 2020
- Primary completion17 Jul 2021
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ana Rodriguez-Mateos, King's College London
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276974
- Sponsor's protocol ID
- HR-19/20-14
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function: the ORGAMIC Pilot Study
- ClinicalTrials.gov ID
- NCT04276974
- Acronym / sponsor ID
- HR-19/20-14
- Conditions
- Healthy Men and Women
- Keywords
- polyphenols, pesticides, plant based food, organic, microbiome, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organic first then non-organic | Experimental | Other: Organic diet, Other: Non-organic dietOrganic diet then non-organic diet, each for 4 consecutive days |
| Non-organic first then organic | Experimental | Other: Organic diet, Other: Non-organic dietNon-organic diet then organic diet, each for 4 consecutive days |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organic dietOrganic plant-rich foods (2000kcal for women, 2500kcal for men) | Other | Non-organic first then organic, Organic first then non-organic |
| Non-organic dietLikewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men) | Other | Non-organic first then organic, Organic first then non-organic |
Primary outcome
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)
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)
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
4 secondary outcomes
Changes in flow-mediated-dilation (FMD) in the brachial artery
Time frame: Baseline & 4 days after
Changes in blood pressure
Time frame: Baseline & 4 days after
Changes in pulse wave velocity (PWV)
Time frame: Baseline & 4 days after
Change in augmentation Index (AIx)
Time frame: Baseline & 4 days after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Rodriguez-Mateos, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic diet and Non-organic diet in people with Healthy Men and Women, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in urinary pesticides levels (time frame: Baseline & 4 days after). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.