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NCT Number: NCT01585519

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

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

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University Belfast, Belfast, Northern Ireland, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: High Polyphenol Apples, Low Polyphenol Apples

Primary outcomes

  1. Between group change in oxidised-LDL

    Time frame: Weeks 0 and 4

Secondary outcomes

  1. Between group change in self-reported apple or apple product intake

    Time frame: Weeks 0 and 4

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study 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

Acronym: APPS

Important dates

Study start
2012
Primary completion
2013
Study completion
2017
First posted
Apr 26, 2012
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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