HealthyCABALANCT03369548
CABALA Diet & Health Study
A study testing Apple, Oats and Lactobacillus reuteri NCIMB 30242 in people with Healthy, run by University of Reading at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Apple, Oats and Lactobacillus reuteri NCIMB 30242
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2017to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smoker
- Diabetes
- Endocrine disease
- Cardiovascular disease diagnosis
- Gastrointestinal diseases
- Pancreatic, hepatic or renal diseases
Show all 18Show fewer
- 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
- Currently taking part or participation in other research studies within the last three months
- Recent blood donation or unwilling to refrain from donating blood during the study
- Regular consumption of probiotic or prebiotic food supplements or fiber based laxatives and unwilling stop consuming these for the duration of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
Julie A Lovegrove, Professor, 0044(0)1183786418 ext. 6418, j.a.lovegrove@reading.ac.uk
Camilla Pedersen, PhD, +44 (0)797 617 6090, C.Pedersen@reading.ac.uk
About this study
Official title: CirculAting Bile Acids as Biomarkers of Metabolic Health - Linking microbiotA, Diet and Health
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
- Being tested
- Apple, Oats, Lactobacillus reuteri NCIMB 30242, Cornflakes
- Keywords
- Bile acids, Lipid metabolism, Cholesterol, Probiotics, Polyphenols, Prebiotics, Gut bacteria, Gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppleOther
Also called Polyphenol
2 Renetta Canada apples and 2 placebo capsules/ day
OatsOther
Also called Prebiotic
40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
Lactobacillus reuteri NCIMB 30242Dietary supplement
Also called Probiotic
2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
CornflakesOther
Also called Placebo
40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.
| Study group | Role | What they receive |
|---|---|---|
| Apple/ Polyphenol | Experimental | Participants will be asked to consume 2 Renetta Canada apples (with skin) and 2 placebo capsules every day for 8 weeks. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Cornflakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating bile acids
Plasma bile acid profile
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary outcomes (19)
Blood lipid profile
total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triacylglycerol (TAG) and non-esterified fatty acids (NEFA)
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Glucose response
Fasting and postprandial blood glucose concentrations
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Insulin response
Fasting and postprandial blood insulin concentrations
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
C-peptide
Fasting and postprandial blood C-peptide concentrations
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Inflammatory markers
Fasting blood concentrations of C-reactive protein (CRP), IL-18, IL-1β and tumour necrosis factor alpha (TNF-α)
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Gut hormones
Fasting and postprandial concentrations of peptide YY, Glucagon-Like Peptide 1, Fibroblast growth factor 19
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Metabolomics
Profile of metabolites in the blood (fasting and postprandial)
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Nitric Oxide
Fasting and postprandial concentrations of nitric oxide
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Cell-adhesion molecules
Fasting and postprandial concentrations of ICAM and VCAM
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Short-chain fatty acids
Fasting and postprandial circulating short-chain fatty acids concentrations and fecal short-chain fatty acid concentrations
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response and faecal sample at both baseline and week 8
LDL receptor expression
LDL receptor expression in peripheral blood mononuclear cells
Measured: This will be measured at baseline
Genotyping of bile acid receptor gene
Genotyping of single-nucleotide polymorphisms (SNPs) in the FXR-encoding gene NR1H4
Measured: This will be measured at baseline
Platelets
Platelets will be collected for in-vitro studies
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Gut microbiota
Next-generation sequencing of gut bacteria and enumeration of selected bacteria using FISH (fecal samples)
Measured: At baseline and week 8
Bile acid excretion
Fecal bile acid concentrations
Measured: At baseline and week 8
Energy excretion
Bomb calorimetry of fecal samples
Measured: At baseline and week 8
Urine metabolites
Markers of intervention foods/ supplements in urine (24h urine collection)
Measured: At baseline and week 8
Blood pressure and heart rate
Ambulatory blood pressure and heart rate
Measured: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Body composition
Body composition measured using bio-impedance
Measured: At baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start4 Dec 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion23 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, Fondazione Edmund Mach, Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369548
- Sponsor's protocol ID
- 17/47
- Acronym
- CABALA
- Status last verified
- Apr 2018
- First submitted
- 1 Dec 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40347281
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CirculAting Bile Acids as Biomarkers of Metabolic Health - Linking microbiotA, Diet and Health
- ClinicalTrials.gov ID
- NCT03369548
- Acronym / sponsor ID
- CABALA / 17/47
- Conditions
- Healthy
- Keywords
- Bile acids, Lipid metabolism, Cholesterol, Probiotics, Polyphenols, Prebiotics, Gut bacteria, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- University College Cork, Fondazione Edmund Mach, Università degli Studi dell'Insubria
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 23 Dec 2019 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apple/ Polyphenol | Experimental | Other: AppleParticipants will be asked to consume 2 Renetta Canada apples (with skin) and 2 placebo capsules every day for 8 weeks. |
| Oats / Prebiotic | Experimental | Other: OatsParticipants will be asked to consume 40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules every day for 8 weeks. |
| Lactobacillus reuteri NCIMB 30242 / Probiotic | Experimental | Dietary Supplement: Lactobacillus reuteri NCIMB 30242Participants will be asked to consume 2 probiotic capsules and 40g cornflakes with semi-skimmed milk every day for 8 weeks. |
| Placebo / cornflakes | Placebo comparator | Other: CornflakesParticipants will be asked to consume 40g cornflakes with semi-skimmed milk and 2 placebo capsules every day for 8 weeks. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women
- Aged 25-70 years
- BMI: 23-32 kg/m2
- Fasting glucose < 7 mmol/l
- Total cholesterol < 7.5 mmol/L
Key exclusion criteria (18 listed)
- Smoker
- Diabetes
- Endocrine disease
- Cardiovascular disease diagnosis
- Gastrointestinal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppleAlso: Polyphenol2 Renetta Canada apples and 2 placebo capsules/ day | Other | Apple/ Polyphenol |
| OatsAlso: Prebiotic40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day | Other | Oats / Prebiotic |
| Lactobacillus reuteri NCIMB 30242Also: Probiotic2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day. | Dietary supplement | Lactobacillus reuteri NCIMB 30242 / Probiotic |
| CornflakesAlso: Placebo40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day. | Other | Placebo / cornflakes |
Primary outcome
Circulating bile acids
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Plasma bile acid profile
19 secondary outcomes
Blood lipid profile
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Glucose response
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Insulin response
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
C-peptide
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Inflammatory markers
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Gut hormones
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Metabolomics
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Nitric Oxide
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Cell-adhesion molecules
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Short-chain fatty acids
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response and faecal sample at both baseline and week 8
LDL receptor expression
Time frame: This will be measured at baseline
Genotyping of bile acid receptor gene
Time frame: This will be measured at baseline
Platelets
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Gut microbiota
Time frame: At baseline and week 8
Bile acid excretion
Time frame: At baseline and week 8
Energy excretion
Time frame: At baseline and week 8
Urine metabolites
Time frame: At baseline and week 8
Blood pressure and heart rate
Time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Body composition
Time frame: At baseline and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 40347281Alzoufairi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Lovegrove, Professor principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple, Oats and Lactobacillus reuteri NCIMB 30242 in people with Healthy, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie A Lovegrove, Professor (0044(0)1183786418 ext. 6418, j.a.lovegrove@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating bile acids (time frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018; AzTrials last refreshed its copy on 30 Oct 2026.