Clinical trial NCT01585519: A Study Examining Effects of Apples/ Apple Products on Heart Disease Risk
Official title: Effect of Increased Whole Apple Consumption, Apple Extract and Freeze-dried Apple Products on Biomarkers of Cardiovascular Disease Risk: a Randomised Intervention in Participants at Increased Risk of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: High Epicatechin Apples
Low Epicatechin Apples
Apple Extract
Apple Granules
Blood Pressure
Cholesterol
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Between group change in oxidised-LDL
timeFrame: Weeks 0 and 4
Secondary outcomes:
measure: Between group change in self-reported apple or apple product intake
timeFrame: Weeks 0 and 4
measure: Between group change in biochemical markers of nutritional status
timeFrame: Weeks 0 and 4
measure: Between group change in biomarkers of cardiovascular disease risk
timeFrame: Weeks 0 and 4
measure: Between group change in other biomarkers of cardiovascular disease risk
timeFrame: Weeks 0 and 4
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Northern Ireland
city: Belfast
country: United Kingdom
facility: Queen's Unversity, Belfast
state: Northern Ireland
Study officials:
affiliation: Queen's University, Belfast
name: Jayne V Woodside, PhD
role: PRINCIPAL_INVESTIGATOR
References: