Status:
COMPLETED
Effects of an Organic Plant-rich Diet on Gut Microbiome and Vascular Function (ORGAMIC Pilot Study)
Lead Sponsor:
King's College London
Conditions:
Healthy Men and Women
Eligibility:
All Genders
20-40 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04276974
Start Date
February 24 2020
End Date
July 17 2021
Last Update
March 3 2022
Active Locations (1)
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1
Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London
London, United Kingdom, SE1 9NH