Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
64 participants
INTERVENTIONAL
2017-12-04
2019-12-23
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Apple/ Polyphenol
Participants will be asked to consume 2 Renetta Canada apples (with skin) and 2 placebo capsules every day for 8 weeks.
Apple
2 Renetta Canada apples and 2 placebo capsules/ day
Oats / Prebiotic
Participants will be asked to consume 40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules every day for 8 weeks.
Oats
40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
Lactobacillus reuteri NCIMB 30242 / Probiotic
Participants will be asked to consume 2 probiotic capsules and 40g cornflakes with semi-skimmed milk every day for 8 weeks.
Lactobacillus reuteri NCIMB 30242
2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
Placebo / cornflakes
Participants will be asked to consume 40g cornflakes with semi-skimmed milk and 2 placebo capsules every day for 8 weeks.
Cornflakes
40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.
Interventions
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Apple
2 Renetta Canada apples and 2 placebo capsules/ day
Oats
40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
Lactobacillus reuteri NCIMB 30242
2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
Cornflakes
40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
25 Years
70 Years
ALL
Yes
Sponsors
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University College Cork
OTHER
Fondazione Edmund Mach
OTHER
Università degli Studi dell'Insubria
OTHER
University of Reading
OTHER
Responsible Party
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Julie Lovegrove
Professor
Principal Investigators
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Julie A Lovegrove, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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17/47
Identifier Type: -
Identifier Source: org_study_id
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