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Trial record 84 of 92 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

CABALA Diet & Health Study (CABALA)

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ClinicalTrials.gov Identifier: NCT03369548
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
University College Cork
Fondazione Edmund Mach
Università degli Studi dell'Insubria
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Apple Other: Oats Dietary Supplement: Lactobacillus reuteri NCIMB 30242 Other: Cornflakes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CirculAting Bile Acids as Biomarkers of Metabolic Health - Linking microbiotA, Diet and Health
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 23, 2019

Arm Intervention/treatment
Experimental: Apple/ Polyphenol
Participants will be asked to consume 2 Renetta Canada apples (with skin) and 2 placebo capsules every day for 8 weeks.
Other: Apple
2 Renetta Canada apples and 2 placebo capsules/ day
Other Name: Polyphenol

Experimental: 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.
Other: Oats
40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
Other Name: Prebiotic

Experimental: 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.
Dietary Supplement: Lactobacillus reuteri NCIMB 30242
2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
Other Name: Probiotic

Placebo Comparator: Placebo / cornflakes
Participants will be asked to consume 40g cornflakes with semi-skimmed milk and 2 placebo capsules every day for 8 weeks.
Other: Cornflakes
40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.
Other Name: Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Blood lipid profile [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triacylglycerol (TAG) and non-esterified fatty acids (NEFA)

  2. Glucose response [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting and postprandial blood glucose concentrations

  3. Insulin response [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting and postprandial blood insulin concentrations

  4. C-peptide [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting and postprandial blood C-peptide concentrations

  5. Inflammatory markers [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting blood concentrations of C-reactive protein (CRP), IL-18, IL-1β and tumour necrosis factor alpha (TNF-α)

  6. Gut hormones [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting and postprandial concentrations of peptide YY, Glucagon-Like Peptide 1, Fibroblast growth factor 19

  7. Metabolomics [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Profile of metabolites in the blood (fasting and postprandial)

  8. Nitric Oxide [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting and postprandial concentrations of nitric oxide

  9. Cell-adhesion molecules [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Fasting and postprandial concentrations of ICAM and VCAM

  10. 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 ]
    Fasting and postprandial circulating short-chain fatty acids concentrations and fecal short-chain fatty acid concentrations

  11. LDL receptor expression [ Time Frame: This will be measured at baseline ]
    LDL receptor expression in peripheral blood mononuclear cells

  12. Genotyping of bile acid receptor gene [ Time Frame: This will be measured at baseline ]
    Genotyping of single-nucleotide polymorphisms (SNPs) in the FXR-encoding gene NR1H4

  13. Platelets [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Platelets will be collected for in-vitro studies

  14. Gut microbiota [ Time Frame: At baseline and week 8 ]
    Next-generation sequencing of gut bacteria and enumeration of selected bacteria using FISH (fecal samples)

  15. Bile acid excretion [ Time Frame: At baseline and week 8 ]
    Fecal bile acid concentrations

  16. Energy excretion [ Time Frame: At baseline and week 8 ]
    Bomb calorimetry of fecal samples

  17. Urine metabolites [ Time Frame: At baseline and week 8 ]
    Markers of intervention foods/ supplements in urine (24h urine collection)

  18. Blood pressure and heart rate [ Time Frame: Chronic and acute effects: Fasting and 6-hour postprandial response at both baseline and week 8 ]
    Ambulatory blood pressure and heart rate

  19. Body composition [ Time Frame: At baseline and week 8 ]
    Body composition measured using bio-impedance



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369548


Contacts
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Contact: Julie A Lovegrove, Professor 0044(0)1183786418 ext 6418 j.a.lovegrove@reading.ac.uk
Contact: Camilla Pedersen, PhD +44 (0)797 617 6090 C.Pedersen@reading.ac.uk

Locations
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United Kingdom
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading Recruiting
Reading, Berkshire, United Kingdom, RG6 6AP
Contact: Julie A Lovegrove, Professor    0044(0)1183786418 ext 6418    j.a.lovegrove@reading.ac.uk   
Contact: Camilla Pedersen, PhD    +44 (0)797 617 6090    C.Pedersen@reading.ac.uk   
Principal Investigator: Julie A Lovegrove, Professor         
Sub-Investigator: Camilla Pedersen, PhD         
Sub-Investigator: Kim Jackson, PhD         
Sub-Investigator: Jeremy Spencer, Professor         
Sponsors and Collaborators
University of Reading
University College Cork
Fondazione Edmund Mach
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Julie A Lovegrove, Professor University of Reading

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Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT03369548     History of Changes
Other Study ID Numbers: 17/47
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Lovegrove, University of Reading:
Bile acids
Lipid metabolism
Cholesterol
Probiotics
Polyphenols
Prebiotics
Gut bacteria
Gut microbiota
Additional relevant MeSH terms:
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Bile Acids and Salts
Gastrointestinal Agents