CABALA Diet & Health Study

Healthy Clinical Trial

— CABALA  

Official title:

CirculAting Bile Acids as Biomarkers of Metabolic Health - Linking microbiotA, Diet and Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03369548
• Other study ID #: 17/47
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2017
• Last updated: April 11, 2018
• Start date: December 4, 2017
• Est. completion date: December 23, 2019

Study information

• Verified date: April 2018
• Source: University of Reading
• Contact: Julie A Lovegrove, Professor
• Phone: 0044(0)1183786418
• Email: j.a.lovegrove[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 23, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Apple
2 Renetta Canada apples and 2 placebo capsules/ day
• 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.

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Reading	Fondazione Edmund Mach, Università degli Studi dell'Insubria, University College Cork

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating bile acids	Plasma bile acid profile	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Blood lipid profile	total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triacylglycerol (TAG) and non-esterified fatty acids (NEFA)	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Glucose response	Fasting and postprandial blood glucose concentrations	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Insulin response	Fasting and postprandial blood insulin concentrations	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	C-peptide	Fasting and postprandial blood C-peptide concentrations	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Inflammatory markers	Fasting blood concentrations of C-reactive protein (CRP), IL-18, IL-1ß and tumour necrosis factor alpha (TNF-a)	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Gut hormones	Fasting and postprandial concentrations of peptide YY, Glucagon-Like Peptide 1, Fibroblast growth factor 19	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Metabolomics	Profile of metabolites in the blood (fasting and postprandial)	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Nitric Oxide	Fasting and postprandial concentrations of nitric oxide	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Cell-adhesion molecules	Fasting and postprandial concentrations of ICAM and VCAM	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Short-chain fatty acids	Fasting and postprandial circulating short-chain fatty acids concentrations and fecal short-chain fatty acid concentrations	Chronic and acute effects: Fasting and 6-hour postprandial response and faecal sample at both baseline and week 8
Secondary	LDL receptor expression	LDL receptor expression in peripheral blood mononuclear cells	This will be measured at baseline
Secondary	Genotyping of bile acid receptor gene	Genotyping of single-nucleotide polymorphisms (SNPs) in the FXR-encoding gene NR1H4	This will be measured at baseline
Secondary	Platelets	Platelets will be collected for in-vitro studies	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Gut microbiota	Next-generation sequencing of gut bacteria and enumeration of selected bacteria using FISH (fecal samples)	At baseline and week 8
Secondary	Bile acid excretion	Fecal bile acid concentrations	At baseline and week 8
Secondary	Energy excretion	Bomb calorimetry of fecal samples	At baseline and week 8
Secondary	Urine metabolites	Markers of intervention foods/ supplements in urine (24h urine collection)	At baseline and week 8
Secondary	Blood pressure and heart rate	Ambulatory blood pressure and heart rate	Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8
Secondary	Body composition	Body composition measured using bio-impedance	At baseline and week 8