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

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT12 6BJ
      • Queen's University Belfast
    • Belfast, Northern Ireland, United Kingdom, BT12 6BJ
      • Queen's Unversity, Belfast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: (Group 1) Low Apple Diet
Experimental: (Group 2) 2 High Apples	Dietary supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules; (Group 1) Low Apple Diet (i.e. <1 portion per day) + 2 placebo capsules daily. (Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily. (Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily. (Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily. (Group 5) Low apple diet + 2 x Apple Extract Capsules daily.; Other Names: High Polyphenol Apples; Low Polyphenol Apples
Experimental: (Group 3) 2 Low Apples	Dietary supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules; (Group 1) Low Apple Diet (i.e. <1 portion per day) + 2 placebo capsules daily. (Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily. (Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily. (Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily. (Group 5) Low apple diet + 2 x Apple Extract Capsules daily.; Other Names: High Polyphenol Apples; Low Polyphenol Apples
Experimental: (Group 4) 2 x 4.4g apple granules	Dietary supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules; (Group 1) Low Apple Diet (i.e. <1 portion per day) + 2 placebo capsules daily. (Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily. (Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily. (Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily. (Group 5) Low apple diet + 2 x Apple Extract Capsules daily.; Other Names: High Polyphenol Apples; Low Polyphenol Apples
Experimental: (Group 5) 2 x Apple Extract Capsules	Dietary supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules; (Group 1) Low Apple Diet (i.e. <1 portion per day) + 2 placebo capsules daily. (Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily. (Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily. (Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily. (Group 5) Low apple diet + 2 x Apple Extract Capsules daily.; Other Names: High Polyphenol Apples; Low Polyphenol Apples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Between group change in oxidised-LDL	Weeks 0 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between group change in self-reported apple or apple product intake		Weeks 0 and 4
Between group change in biochemical markers of nutritional status	Polyphenol levels (including epicatechin and quercetin) in plasma. Vitamin C and carotenoid concentrations in serum. Polyphenol and carotenoid concentrations in LDL.	Weeks 0 and 4
Between group change in biomarkers of cardiovascular disease risk	Blood pressure will be measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes. Total cholesterol, HDL cholesterol and triglycerides in serum will be measured using automated enzymatic assays. High sensitivity CRP will be assessed by automated immunoassay. Weight will be monitored weekly over the 4 week intervention.	Weeks 0 and 4
Between group change in other biomarkers of cardiovascular disease risk	Isoprostanes in urine by ELISA. Serum ICAM-1, VCAM-1 and E-selectin, LDL particle size, malondialdehyde in serum by HPLC.	Weeks 0 and 4

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Investigators: Principal Investigator: Jayne V Woodside, PhD, Queen's University, Belfast

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimated): April 26, 2012

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cholesterol; Blood Pressure; High Epicatechin Apples; Low Epicatechin Apples; Apple Extract; Apple Granules
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 11.22v5