CABALA Diet & Health Study

University of Reading

Status: Unknown

Conditions: Healthy

Treatments: Other: Cornflakes; Other: Apple; Other: Oats; Dietary Supplement: Lactobacillus reuteri NCIMB 30242

Study type: Interventional

Funder types: Other

Identifiers

NCT03369548

17/47

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups, including a placebo group

Apple/ Polyphenol

Experimental group

Description:

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

Treatment:

Other: Apple

Oats / Prebiotic

Experimental group

Description:

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

Treatment:

Other: Oats

Lactobacillus reuteri NCIMB 30242 / Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus reuteri NCIMB 30242

Placebo / cornflakes

Placebo Comparator group

Description:

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

Treatment:

Other: Cornflakes