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

This study is currently recruiting participants.
Verified November 2012 by Queen's University, Belfast
Sponsor:
Information provided by (Responsible Party):
Jayne Woodside, PhD, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01585519
First received: April 19, 2012
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Heart Diseases
Drug Information available for: Cianidanol
U.S. FDA Resources

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

Primary Outcome Measures:
  • Between group change in oxidised-LDL [ Time Frame: Weeks 0 and 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Between group change in self-reported apple or apple product intake [ Time Frame: Weeks 0 and 4 ] [ Designated as safety issue: No ]
  • Between group change in biochemical markers of nutritional status [ Time Frame: Weeks 0 and 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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: April 2013
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585519

Contacts
Contact: Sharon L Fulton +44 (0) 2890 63 ext 5020 sfulton05@qub.ac.uk
Contact: Jayne V Woodside +44 (0) 2890 63 ext 2585 j.woodside@qub.ac.uk

Locations
United Kingdom
Queen's Unversity, Belfast Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Contact: Sharon L Fulton     +44 (0) 289063 ext 5020     sfulton05@qub.ac.uk    
Contact: Jayne V Woodside     +44 (0) 289063 ext 2585     j.woodside@qub.ac.uk    
Principal Investigator: Jayne V Woodside            
Queen's University Belfast Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Contact: Sharon L Fulton     +44 (0) 2890 63 ext 5020     sfulton05@qub.ac.uk    
Contact: Jayne V Woodside     +44 (0) 2890 63 ext 2585     j.woodside@qub.ac.uk    
Principal Investigator: Jayne V Woodside            
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Jayne V Woodside, PhD Queen's University, Belfast
  More Information

No publications provided

Responsible Party: Jayne Woodside, PhD, Reader, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01585519     History of Changes
Other Study ID Numbers: 11.22v5
Study First Received: April 19, 2012
Last Updated: November 22, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013