Effect of Apples on cardioVascular Risk And Gut Health

Study Overview
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Brief Summary
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There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Epidemiological studies have linked frequent apple consumption with several health benefits including a reduced risk of cardiovascular disease. Apples are an important source of polyphenols and fiber and their beneficial effects could be attributed to this content; however, their impact on our health is not clear. Although, there are some studies that have reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies have explored the impact on vascular function and gut microbiota. The objective of the current study is to assess whether a regular apple consumption, reduces total cholesterol levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic subjects compared with a control, sugar matched commercial clear apple juice squash.

Official Title
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Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects

Conditions
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Mild Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: whole apples (WA)
* Dietary Supplement: apple juice (AJ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mildly hypercholesterolemic: TC>5.2 and <7.9 mmol/L BMI: 20-35 Age: 23-69 Normal liver and kidney function Exclusion Criteria: Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation. Vegetarians. Smoking. History of alcohol misuse. History of food allergy (e.g. apples, sulphites). Taking antibiotics for the previous 3 months. Taking phytochemical, antioxidant, fish oil supplements, or prebiotic/probiotic preparations unless willing to stop for the study period and after a 4 week wash out period (8 weeks for fish oil). Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence). Medical history of cardiovascular disease including coronary heart disease (angina and heart attack) and stroke (in the past 12 months). Family history of cardiovascular disease (their father or brother was under 55 or their mother or sister was under 65 when they were diagnosed with cardiovascular disease). Diabetes mellitus. Kidney, liver, pancreas or gastrointestinal diseases. Hematologic disorders (i.e. anaemia; men:haemoglobin<13.8g/dl (8.56mmol/L) and women<12.1 g/dl (5.51mmol/L)). Planning a weight reducing regime. Parallel participation in another dietary intervention study.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole apples<br>Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet | Dietary Supplement: whole apples (WA)<br> <br> |
| Other: apple juice squash<br>Subjects are asked to consume 100 ml of apple juice squash (recommended dilution with water up to 500 ml) for 8 weeks in addition to their habitual diet. The apple juice is used as a sugar matched control. | Dietary Supplement: apple juice (AJ)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood lipid levels |  | Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of endothelial function by using laser doppler iontophoresis (LDI) |  | Baseline and assessment at 8 weeks for each intervention arm. | 
| Changes in vascular stiffness by pulse wave analysis (PWA) |  | Baseline and assessment at 8 weeks for each intervention arm | 
| Changes in faecal bacterial population |  | Baseline and assessment at 8 weeks for each intervention arm | 
| Ambulatory blood pressure | Blood pressure will be recorded for 30 minutes at baseline and at 8 weeks for each intervention arm | Baseline and assessment at 8 weeks for each intervention arm | 
| Changes in inflammatory, endothelial function and oxidative stress markers |  | Baseline and assessment at 8 weeks for each intervention arm | 
| Changes in insulin resistance and gut hormones |  | Baseline and assessment at 8 weeks for each intervention arm | 
| Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample). |  | Baseline and assessment at 8 weeks for each intervention arm |