Clinical Trials Directory

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UnknownNCT03369548

CABALA Diet & Health Study

CirculAting Bile Acids as Biomarkers of Metabolic Health - Linking microbiotA, Diet and Health

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
University of Reading · Academic / Other
Sex
All
Age
25 Years – 70 Years
Healthy volunteers
Accepted

Summary

During digestion of fatty foods, the liver produces a substance called bile which helps with the absorption of fat in the gut (small intestine). Some research studies have shown that friendly bacteria that live in our gut can change the makeup of bile (referred to as bile acids) leading to a lowering of blood cholesterol levels, an important risk factor for developing heart disease. This finding has been found in people who consume diets high in dietary fibers and probiotics that enhance the growth of friendly gut bacteria, and also plant rich foods high in polyphenols (such as apples). At present, very little is known about how the makeup of bile acids can regulate blood cholesterol levels and if their measurement in blood, urine or stool samples can be used as an indicator of human health. The aim of this study is to explore how consumption of foods which enhance the growth of friendly gut bacteria (such as probiotics, prebiotics, and plant rich foods high in polyphenols) can change the makeup of bile acids after 8 weeks. Changes in the bile acids measured in blood and stool samples will then be related to markers of health, such as blood cholesterol, glucose, insulin, vascular health and inflammatory markers.

Conditions

Interventions

TypeNameDescription
OTHERApple2 Renetta Canada apples and 2 placebo capsules/ day
OTHEROats40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
DIETARY_SUPPLEMENTLactobacillus reuteri NCIMB 302422 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
OTHERCornflakes40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.

Timeline

Start date
2017-12-04
Primary completion
2019-11-30
Completion
2019-12-23
First posted
2017-12-12
Last updated
2018-04-12

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03369548. Inclusion in this directory is not an endorsement.