A Study Examining Effects of Apples/ Apple Products on Heart Disease Risk (APPS)

Queen's University Belfast

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT01585519

11.22v5

Details and patient eligibility

About

This study will examine if health benefits of consuming nutrient-rich apples, an apple extract and freeze dried apple product will be similar. 50 volunteers at increased risk of heart disease will consume either a low apple diet (<1 portion/d), 2 high or low polyphenol apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten participants per group, randomly assigned). Apart from the extract group, all volunteers will consume a placebo. All volunteers will follow a low apple diet (<1 apple per day) other than what has been provided by the research team. Volunteers will complete food diaries at the start and end of the study and a number of questionnaires. Blood and urine samples collected at 0 and 4 weeks

Full description

Many products (such as bioactive extracts) attempt to replicate health benefits of a diet rich in fruit and vegetables, however, it is not known whether similar health benefits can be gained from consuming these processed products. A placebo-controlled intervention study will examine if health benefits are similar between products. Volunteers will have one risk factor for heart disease. Recruitment will be by advertisement from QUB and general public. Apples/apple products will be provided for the 4 weeks, but otherwise volunteers' normal diet and lifestyle will be followed. Blood and urine samples will be collected at week 0 and week 4. 4-day food diaries will be completed at the start and end of the study. A number of questionnaires (physical activity, lifestyle, levels of liking, tolerability to study products, study evaluation) will be completed at the start and end of the study. As this is a pilot study, power calculations were not considered appropriate. Statistical analysis will be carried out in SPSS, each endpoint of interest from the week 0 measure will be compared between the five intervention groups by one way analysis of variance.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• > 50 years old or
• Current Smoker or
• Systolic Blood Pressure 120-139mmHg/ Diastolic Blood Pressure 80-89mmHg or
• Total Cholesterol >5.2mmol/l or HDL cholesterol <1.03mmol/l or
• BMI >25 kg/m2

Exclusion criteria

• Diabetes mellitus
• An acute coronary syndrome or transient ischaemic attack within the past 3 months
• Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
• Oral anticoagulation therapy
• BMI >35 kg/m2
• Excessive alcohol consumption (>28 U/week men or >21 U/week women)
• Pregnancy/ lactation
• Taking antioxidant supplements
• Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 5 patient groups

(Group 1) Low Apple Diet

No Intervention group

(Group 2) 2 High Apples

Experimental group

Treatment:

Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules

(Group 3) 2 Low Apples

Experimental group

Treatment:

Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules

(Group 4) 2 x 4.4g apple granules

Experimental group

Treatment:

Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules

(Group 5) 2 x Apple Extract Capsules

Experimental group

Treatment:

Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules