CABALA Diet & Health Study
NCT03369548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2018-04-12
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
- Healthy
Interventions
- OTHER
-
Apple
2 Renetta Canada apples and 2 placebo capsules/ day
- OTHER
-
Oats
40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
- DIETARY_SUPPLEMENT
-
Lactobacillus reuteri NCIMB 30242
2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
- OTHER
-
Cornflakes
40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.
Sponsors & Collaborators
-
University College Cork
collaborator OTHER -
Fondazione Edmund Mach
collaborator OTHER -
Università degli Studi dell'Insubria
collaborator OTHER -
University of Reading
lead OTHER
Principal Investigators
-
Julie A Lovegrove, Professor · University of Reading
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-04
- Primary Completion
- 2019-11-30
- Completion
- 2019-12-23
Countries
- United Kingdom
Study Locations
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