Clinical trial NCT03840746: Interactions Between Fibre and Polyphenols on Colonic Phenolic Acid Production and Biomarkers of Health ( 6 Weeks)
Official title: 6 Week Feeding Study of Interactions Between Fibre and Polyphenols Sources on Colonic Phenolic Acid Production and Biomarkers of Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: self-reported healthy adults
age 40-70
BMI > 25
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Scottish Universities Environmental Research Centre
First posted: 2019-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators have studied the acute interactions of polyphenols and NDC in a single meal in a human study containing tomatoes, lovage \& onions, with and without inulin. The investigators now wish to study the longer-term interactions of these foods over 6 weeks as well as their impact on biomarkers of human health, the gut microbiome, human proteome and markers of risk of chronic disease. This may allow better targeted evaluation of foods which influence health through the gut microbiome.

Detailed description: Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty acids. It is likely that there are key interactions in the colonic bacterial metabolism of NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic health.

Eligibility criteria: Inclusion Criteria:

* Generally healthy
* BMI\>=25
* Not on antibiotics within 3 months of starting of study
* No medication likely to influence gut function, colonic bacterial activity.

Exclusion Criteria:

* Antibiotics
* Pregnancy
* lactation

Primary outcomes:
measure: Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)
timeFrame: 3 weeks
measure: Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
state: Scotland
Study officials:
References: