Cardiovascular DiseaseAPPSNCT01585519
A Study Examining Effects of Apples/ Apple Products on Heart Disease Risk
A study testing High/ Low Epicatechin Apples/ Apple Extract/ Granules in people with Cardiovascular Disease, run by Queen's University, Belfast at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- High/ Low Epicatechin Apples/ Apple Extract/ Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2012to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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)
Show all 9Show fewer
- Pregnancy/ lactation
- Taking antioxidant supplements
- Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen's University Belfast
Belfast, Northern Ireland, BT12 6BJ
Queen's Unversity, Belfast
Belfast, Northern Ireland, BT12 6BJ
About this study
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
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
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- High/ Low Epicatechin Apples/ Apple Extract/ Granules
- Keywords
- High Epicatechin Apples, Low Epicatechin Apples, Apple Extract, Apple Granules, Blood Pressure, Cholesterol
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High/ Low Epicatechin Apples/ Apple Extract/ GranulesDietary supplement
Also called High Polyphenol Apples, Low Polyphenol Apples
(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.
| Study group | Role | What they receive |
|---|---|---|
| (Group 1) Low Apple Diet | No intervention | Not described |
| (Group 2) 2 High Apples | Experimental | Not described Receives: Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules |
| (Group 3) 2 Low Apples | Experimental | Not described Receives: Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules |
| (Group 4) 2 x 4.4g apple granules | Experimental | Not described Receives: Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules |
| (Group 5) 2 x Apple Extract Capsules | Experimental | Not described Receives: Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group change in oxidised-LDL
Measured: Weeks 0 and 4
Secondary outcomes (4)
Between group change in self-reported apple or apple product intake
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayne Woodside, PhD, Queen's University, Belfast
- Investigators
- Jayne V Woodside, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585519
- Sponsor's protocol ID
- 11.22v5
- Acronym
- APPS
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2012
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01585519
- Acronym / sponsor ID
- APPS / 11.22v5
- Conditions
- Cardiovascular Disease
- Keywords
- High Epicatechin Apples, Low Epicatechin Apples, Apple Extract, Apple Granules, Blood Pressure, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High/ Low Epicatechin Apples/ Apple Extract/ GranulesAlso: High Polyphenol Apples, Low Polyphenol Apples(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. | Dietary supplement | (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 |
Primary outcome
Between group change in oxidised-LDL
Time frame: Weeks 0 and 4
4 secondary outcomes
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
Between group change in biomarkers of cardiovascular disease risk
Time frame: Weeks 0 and 4
Between group change in other biomarkers of cardiovascular disease risk
Time frame: Weeks 0 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne V Woodside, PhD principal investigator
Queen's University, Belfast
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High/ Low Epicatechin Apples/ Apple Extract/ Granules in people with Cardiovascular Disease, run by Queen's University, Belfast at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group change in oxidised-LDL (time frame: Weeks 0 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.