Mild HypercholesterolemiaAVAGNCT01988389
Effect of Apples on cardioVascular Risk And Gut Health
A study testing whole apples (WA) and apple juice (AJ) in people with Mild Hypercholesterolemia, run by University of Reading at 1 site in United Kingdom.
Trial summary
There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Read more about this study
- Who is it for?
- Ages 23 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Hypercholesterolemia
- What is being tested?
- whole apples (WA) and apple juice (AJ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Nov 2014
- 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 23 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mildly hypercholesterolemic: TC>5.2 and <7.9 mmol/L
- BMI: 20-35
- Age: 23-69
- Normal liver and kidney function
Who cannot join
- Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation.
- Vegetarians.
- Smoking.
- History of alcohol misuse.
- History of food allergy (e.g. apples, sulphites).
- Taking antibiotics for the previous 3 months.
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- Taking phytochemical, antioxidant, fish oil supplements, or prebiotic/probiotic preparations unless willing to stop for the study period and after a 4 week wash out period (8 weeks for fish oil).
- Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence).
- Medical history of cardiovascular disease including coronary heart disease (angina and heart attack) and stroke (in the past 12 months).
- Family history of cardiovascular disease (their father or brother was under 55 or their mother or sister was under 65 when they were diagnosed with cardiovascular disease).
- Diabetes mellitus.
- Kidney, liver, pancreas or gastrointestinal diseases.
- Hematologic disorders (i.e. anaemia; men:haemoglobin<13.8g/dl (8.56mmol/L) and women<12.1 g/dl (5.51mmol/L)).
- Planning a weight reducing regime.
- Parallel participation in another dietary intervention study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
About this study
Official title: Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects
There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Epidemiological studies have linked frequent apple consumption with several health benefits including a reduced risk of cardiovascular disease. Apples are an important source of polyphenols and fiber and their beneficial effects could be attributed to this content; however, their impact on our health is not clear. Although, there are some studies that have reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies have explored the impact on vascular function and gut microbiota. The objective of the current study is to assess whether a regular apple consumption, reduces total cholesterol levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic subjects compared with a control, sugar matched commercial clear apple juice squash.
- Conditions
- Mild Hypercholesterolemia
- Being tested
- whole apples (WA), apple juice (AJ)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole apples (WA)Dietary supplement
apple juice (AJ)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| whole apples | Experimental | Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet Receives: Dietary Supplement: whole apples (WA) |
| apple juice squash | Other | Subjects are asked to consume 100 ml of apple juice squash (recommended dilution with water up to 500 ml) for 8 weeks in addition to their habitual diet. The apple juice is used as a sugar matched control. Receives: Dietary Supplement: apple juice (AJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood lipid levels
Measured: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period.
Secondary outcomes (7)
Evaluation of endothelial function by using laser doppler iontophoresis (LDI)
Measured: Baseline and assessment at 8 weeks for each intervention arm.
Changes in vascular stiffness by pulse wave analysis (PWA)
Measured: Baseline and assessment at 8 weeks for each intervention arm
Changes in faecal bacterial population
Measured: Baseline and assessment at 8 weeks for each intervention arm
Ambulatory blood pressure
Blood pressure will be recorded for 30 minutes at baseline and at 8 weeks for each intervention arm
Measured: Baseline and assessment at 8 weeks for each intervention arm
Changes in inflammatory, endothelial function and oxidative stress markers
Measured: Baseline and assessment at 8 weeks for each intervention arm
Changes in insulin resistance and gut hormones
Measured: Baseline and assessment at 8 weeks for each intervention arm
Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample).
Measured: Baseline and assessment at 8 weeks for each intervention arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild HypercholesterolemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Edmund Mach di San Michele all'Adige
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, BSc, PhD, RNutr, Principal investigator, University of ReadingKieran Tuohy, Dr, Principal investigator, FEM-IASMA Research and Innovation centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988389
- Sponsor's protocol ID
- 13/22
- Other IDs
- University of Reading
- Acronym
- AVAG
- Status last verified
- Mar 2015
- First submitted
- 10 Oct 2013
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koutsos A, Riccadonna S, Ulaszewska MM, Franceschi P, Trost K, Galvin A, Braune T, Fava F, Perenzoni D, Mattivi F, Tuohy KM, Lovegrove JA. Two apples a day lower serum cholesterol and improve cardiometabolic biomarkers in mildly hypercholesterolemic adults: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Feb 1;111(2):307-318. doi: 10.1093/ajcn/nqz282.
PubMed 31840162
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT01988389
- Acronym / sponsor ID
- AVAG / 13/22
- Conditions
- Mild Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Fondazione Edmund Mach di San Michele all'Adige
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Nov 2013 (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.
There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Epidemiological studies have linked frequent apple consumption with several health benefits including a reduced risk of cardiovascular disease. Apples are an important source of polyphenols and fiber and their beneficial effects could be attributed to this content; however, their impact on our health is not clear. Although, there are some studies that have reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies have explored the impact on vascular function and gut microbiota. The objective of the current study is to assess whether a regular apple consumption, reduces total cholesterol levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic subjects compared with a control, sugar matched commercial clear apple juice squash.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole apples | Experimental | Dietary Supplement: whole apples (WA)Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet |
| apple juice squash | Other | Dietary Supplement: apple juice (AJ)Subjects are asked to consume 100 ml of apple juice squash (recommended dilution with water up to 500 ml) for 8 weeks in addition to their habitual diet. The apple juice is used as a sugar matched control. |
Who may qualify
- Ages
- 23 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mildly hypercholesterolemic: TC>5.2 and <7.9 mmol/L
- BMI: 20-35
- Age: 23-69
- Normal liver and kidney function
Key exclusion criteria (15 listed)
- Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation.
- Vegetarians.
- Smoking.
- History of alcohol misuse.
- History of food allergy (e.g. apples, sulphites).
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 |
|---|---|---|
| whole apples (WA) | Dietary supplement | whole apples |
| apple juice (AJ) | Dietary supplement | apple juice squash |
Primary outcome
Changes in blood lipid levels
Time frame: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period.
7 secondary outcomes
Evaluation of endothelial function by using laser doppler iontophoresis (LDI)
Time frame: Baseline and assessment at 8 weeks for each intervention arm.
Changes in vascular stiffness by pulse wave analysis (PWA)
Time frame: Baseline and assessment at 8 weeks for each intervention arm
Changes in faecal bacterial population
Time frame: Baseline and assessment at 8 weeks for each intervention arm
Ambulatory blood pressure
Time frame: Baseline and assessment at 8 weeks for each intervention arm
Changes in inflammatory, endothelial function and oxidative stress markers
Time frame: Baseline and assessment at 8 weeks for each intervention arm
Changes in insulin resistance and gut hormones
Time frame: Baseline and assessment at 8 weeks for each intervention arm
Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample).
Time frame: Baseline and assessment at 8 weeks for each intervention arm
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 9 Mar 2015.
- Derived from this study: PubMed 31840162Koutsos A, Riccadonna S, Ulaszewska MM, Franceschi P, Trost K, Galvin A, Braune T, Fava F, Perenzoni D, Mattivi F, Tuohy KM, Lovegrove JA. Two apples a day lower serum cholesterol and improve cardiometabolic biomarkers in mildly hypercholesterolemic adults: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Feb 1;111(2):307-318. doi: 10.1093/ajcn/nqz282.
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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.
Julie A Lovegrove, BSc, PhD, RNutr principal investigator
University of Reading
Kieran Tuohy, Dr principal investigator
FEM-IASMA Research and Innovation centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole apples (WA) and apple juice (AJ) in people with Mild Hypercholesterolemia, run by University of Reading at 1 site 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 4 inclusion and 15 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in blood lipid levels (time frame: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988389, which also lists 1 linked publication.
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 9 Mar 2015.