Effect of Apples on cardioVascular Risk And Gut Health (AVAG)

University of Reading

Status: Completed

Conditions: Mild Hypercholesterolemia

Treatments: Dietary Supplement: apple juice (AJ); Dietary Supplement: whole apples (WA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01988389

University of Reading (Other Identifier)

13/22

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 23 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

whole apples

Experimental group

Description:

Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet

Treatment:

Dietary Supplement: whole apples (WA)

apple juice squash

Other group

Description:

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.

Treatment:

Dietary Supplement: apple juice (AJ)