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

NCT01585519 | Completed DMC

• 1 other identifier: 11.22v5
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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

Conditions

Cardiovascular Disease

Keywords

High Epicatechin Apples; Low Epicatechin Apples; Apple Extract; Apple Granules; Blood Pressure; Cholesterol

Outcome Measures

Primary Outcomes (1)

• Between group change in oxidised-LDL

  Weeks 0 and 4

Secondary Outcomes (4)

• Between group change in self-reported apple or apple product intake

  Weeks 0 and 4

• Between group change in biochemical markers of nutritional status

  Weeks 0 and 4

• Between group change in biomarkers of cardiovascular disease risk

  Weeks 0 and 4

• Between group change in other biomarkers of cardiovascular disease risk

  Weeks 0 and 4

Study Arms (5)

(Group 1) Low Apple Diet

NO INTERVENTION

(Group 2) 2 High Apples

EXPERIMENTAL

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

(Group 3) 2 Low Apples

EXPERIMENTAL

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

(Group 4) 2 x 4.4g apple granules

EXPERIMENTAL

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

(Group 5) 2 x Apple Extract Capsules

EXPERIMENTAL

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

Interventions

High/ Low Epicatechin Apples/ Apple Extract/ Granules DIETARY_SUPPLEMENT

(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.

Also known as: High Polyphenol Apples, Low Polyphenol Apples

(Group 2) 2 High Apples; (Group 3) 2 Low Apples; (Group 4) 2 x 4.4g apple granules; (Group 5) 2 x Apple Extract Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (2)

Queen's University Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Queen's Unversity, Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jayne V Woodside, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 26, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: July 31, 2017
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

GB (2)