CABALA Diet & Health Study

NCT03369548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-04-12

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369548 on ClinicalTrials.gov