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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Jayne Woodside, PhD, Queen's University, Belfast.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585519
First Posted: April 26, 2012
Last Update Posted: October 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jayne Woodside, PhD, Queen's University, Belfast
  Purpose
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

Condition Intervention
Cardiovascular Disease Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jayne Woodside, PhD, Queen's University, Belfast:

Primary Outcome Measures:
  • Between group change in oxidised-LDL [ Time Frame: Weeks 0 and 4 ]

Secondary Outcome Measures:
  • Between group change in self-reported apple or apple product intake [ Time Frame: Weeks 0 and 4 ]
  • Between group change in biochemical markers of nutritional status [ Time Frame: Weeks 0 and 4 ]
    Polyphenol levels (including epicatechin and quercetin) in plasma. Vitamin C and carotenoid concentrations in serum. Polyphenol and carotenoid concentrations in LDL.

  • Between group change in biomarkers of cardiovascular disease risk [ Time Frame: Weeks 0 and 4 ]

    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.


  • Between group change in other biomarkers of cardiovascular disease risk [ Time Frame: Weeks 0 and 4 ]
    Isoprostanes in urine by ELISA. Serum ICAM-1, VCAM-1 and E-selectin, LDL particle size, malondialdehyde in serum by HPLC.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585519


Locations
United Kingdom
Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Queen's Unversity, Belfast
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Jayne V Woodside, PhD Queen's University, Belfast
  More Information

Responsible Party: Jayne Woodside, PhD, Reader, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01585519     History of Changes
Other Study ID Numbers: 11.22v5
First Submitted: April 19, 2012
First Posted: April 26, 2012
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Jayne Woodside, PhD, Queen's University, Belfast:
High Epicatechin Apples
Low Epicatechin Apples
Apple Extract
Apple Granules
Blood Pressure
Cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases