NCT03369548

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

December 1, 2017

Last Update Submit

April 11, 2018

Conditions

Healthy

Keywords

Bile acidsLipid metabolismCholesterolProbioticsPolyphenolsPrebioticsGut bacteriaGut microbiota

Outcome Measures

Primary Outcomes (1)

  • Circulating bile acids

    Plasma bile acid profile

    Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8

Secondary Outcomes (19)

  • Blood lipid profile

    Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8

  • Glucose response

    Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8

  • Insulin response

    Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8

  • C-peptide

    Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8

  • Inflammatory markers

    Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8

  • +14 more secondary outcomes

Study Arms (4)

Apple/ Polyphenol

EXPERIMENTAL

Participants will be asked to consume 2 Renetta Canada apples (with skin) and 2 placebo capsules every day for 8 weeks.

Other: Apple

Oats / Prebiotic

EXPERIMENTAL

Participants will be asked to consume 40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules every day for 8 weeks.

Other: Oats

Lactobacillus reuteri NCIMB 30242 / Probiotic

EXPERIMENTAL

Participants will be asked to consume 2 probiotic capsules and 40g cornflakes with semi-skimmed milk every day for 8 weeks.

Dietary Supplement: Lactobacillus reuteri NCIMB 30242

Placebo / cornflakes

PLACEBO COMPARATOR

Participants will be asked to consume 40g cornflakes with semi-skimmed milk and 2 placebo capsules every day for 8 weeks.

Other: Cornflakes

Interventions

AppleOTHER

2 Renetta Canada apples and 2 placebo capsules/ day

Also known as: Polyphenol
Apple/ Polyphenol
OatsOTHER

40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day

Also known as: Prebiotic
Oats / Prebiotic
Lactobacillus reuteri NCIMB 30242DIETARY_SUPPLEMENT

2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.

Also known as: Probiotic
Lactobacillus reuteri NCIMB 30242 / Probiotic
CornflakesOTHER

40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.

Also known as: Placebo
Placebo / cornflakes

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • Aged 25-70 years
  • BMI: 23-32 kg/m2
  • Fasting glucose \< 7 mmol/l
  • Total cholesterol \< 7.5 mmol/L
  • Triglycerides \< 2.3 mmol/L
  • Habitual breakfast consumers
  • Weight stable in the last three months

You may not qualify if:

  • Smoker
  • Diabetes
  • Endocrine disease
  • Cardiovascular disease diagnosis
  • Gastrointestinal diseases
  • Pancreatic, hepatic or renal diseases
  • Medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
  • Antibiotic use within the last three months
  • Food allergies (e.g. gluten, dairy, apples) and intolerances (e.g. lactose)
  • Alcohol or drug abuse (Drink more than 14 units of alcohol per week)
  • Anemia (men:haemoglobin\<130g/ L and women \<120 g/L
  • Planning or currently on a weight reducing program
  • Pregnancy, planned pregnancy in the next year or lactating
  • Irregular menstrual cycle
  • Planning or currently on a weight reducing program
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

RECRUITING

Related Publications (1)

  • Alzoufairi S, Pushpass RG, Liu L, Lovegrove JA, Jackson KG. Impact of chronic consumption of probiotics, oats, and apples on expression of genes related to bile acids, lipid, gut peptides, and inflammation in peripheral monocular cells - findings from the CABALA study. Eur J Nutr. 2025 May 10;64(4):176. doi: 10.1007/s00394-025-03694-x.

    PMID: 40347281DERIVED

MeSH Terms

Interventions

PolyphenolsPrebioticsProbiotics

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Julie A Lovegrove, Professor

    University of Reading

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie A Lovegrove, Professor

CONTACT

0044(0)1183786418j.a.lovegrove@reading.ac.uk

Camilla Pedersen, PhD

CONTACT

+44 (0)797 617 6090C.Pedersen@reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 12, 2017

Study Start

December 4, 2017

Primary Completion

November 30, 2019

Study Completion

December 23, 2019

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations

GB(1)