High LDL-cholesterol LevelsPhase 2AppleCorNCT03795324
Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors.
A Phase 2 study testing Redlove Apple intervention, Green Apple intervention and Aronia drink intervention in people with High LDL-cholesterol Levels, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins, and its effect on cardiometabolic risk factors, in two different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High LDL-cholesterol Levels
- What is being tested?
- Redlove Apple intervention, Green Apple intervention and Aronia drink intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2019to Feb 2020
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years old.
- LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl.
- Sign the informed consent provided before the initial screening visit.
Who cannot join
- LDL-cholesterol levels ≤115 mg/dl and <190 mg/dl.
- Use of hypolipemiant treatment (drugs and functional foods), or hypoglucaemiant treatment.
- Having diabetes mellitus type 1 or type 2.
- BMI values ≥35kg/m2.
- Present triglycerides levels ≥350mg/dl.
- Presenting anemia (hemoglobin ≤13g/dl in men and ≤12g/dl in women).
Show all 16Show fewer
- Subjects diagnosed of intestinal disorders such as Chron disease, colitis ulcerous, celiac disease and irritable bowel syndrome.
- Present fructose and/or sorbitol and/or gluten intolerance.
- Present clinical active chronic disease
- Use of antioxidants supplements.
- Being pregnant or intending to become pregnant.
- Be in breastfeeding period.
- Present chronic alcoholism.
- Tobacco use.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Being unable to follow the study guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors: Innovation in Crop and Application to Health.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins, and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
Read the detailed description
The worldwide high prevalence of cardiovascular disease (CVD) requires lifestyle changes and new dietary prevention strategies based on the increased intake of foods rich in bioactive compounds, as they are considered as key mediators in the improvement of CVD risk factors.
Regarding the health impact on anthocyanins in cardiometalic risk factors and CVD, it has been reported that the dietary intake of anthocyanidins, among other classes of flavonoids, is inversely associated with the risk of CVD in both European and US population. A recent systematic review of human randomized controlled trials assessing the impact of anthocyanins on CVD markers concluded that one of the main modulated outcomes is the decrease of serum LDLc. However, diet does not appear to be sufficient to guarantee the necessary intake to obtain the health benefits specified. Due to previous positive results, a new dietetic strategy based on biofortification to enhance the levels of phenolic compounds is proposed in the present project.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
Participants will be 120 free-living volunteers (men and women) with high LDL-cholesterol levels (LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl) who will be assigned to one of the three arms for 6-week period of dietary treatment. The design of the intervention study is controlled, parallel and randomized. The intervention will combine acute (post-prandial) and chronic effects.
The sample size was computed to be sufficient to detect differences between treatment groups regarding the evolution in time of LDL-cholesterol levels. Justification of chosen sample size is based on assuming a 0.50mmol/l (approximately 15%) post-intervention difference of LDL-cholesterol and a 0.72mmol/l Standard deviation (SD), with α=0.05 and 1-β=0.08 a minimum of 22 participants were required. However the sample size will be 40 participants for arm, in total 120 subjects.
For the acute study, the investigators have chosen n=10 subjects per arm according to the most studies that have addressed the metabolic effects of a postprandial intervention have been performed using a very similar number of subjects with statistically good quality results.
- Conditions
- High LDL-cholesterol Levels
- Being tested
- Redlove Apple intervention, Green Apple intervention, Aronia drink intervention
- Keywords
- Anthocyanins, apple, biofortification, cardiometabolic, LDL cholesterol, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redlove Apple interventionOther
The bioactive compounds present in this product are anthocyanins (50mg per 80g of product).It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized redlove apple.
Green Apple interventionOther
It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized green apple.
Aronia drink interventionOther
The bioactive compounds present in this extract are anthocyanins (50mg per 1L of water).It was a 6 weeks nutritional intervention. Volunteers will drink 1L per day of an aronia drink
| Study group | Role | What they receive |
|---|---|---|
| Redlove Apple | Experimental | Redlove Apple intervention
This product is a biofortified cultivar apple with anthocyanins. Receives: Other: Redlove Apple intervention |
| Green Apple | Experimental | Green Apple intervention
This product is a common cultivar apple without anthocyanins. Receives: Other: Green Apple intervention |
| Aronia Drink | Experimental | Aronia drink intervention
This product is an infusion of aronia fruit extract rich in anthocyanin. Receives: Other: Aronia drink intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum LDL-cholesterol (measured in mg/dL)
Serum lipids will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). Then, LDL-cholesterol will be alculated by the Friedewald formula.
Measured: 6 weeks, week 1 and week 6
Secondary outcomes (15)
Changes in parameters of body composition (weight measured in kg)
Trained dieticians measure weight using a body composition analyzer (Tanita SC 330-S; Tanita Corp., Barcelona, Sapin)
Measured: 6 weeks, week 1, week 2, week 4 and week 6
Parameters of body composition (height measured in meters)
Trained dieticians measure height using a well mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain).
Measured: 6 weeks, week 1
Changes in parameters of body composition (BMI measured in kg/m2)
Body mass index (BMI) is calculated as the ratio between measured weight (kg)/and the square of height (m).
Measured: 6 weeks, week 1, week 2, week 4 and week 6
Changes in parameters of body composition (waist circumference measured in cm)
Waist circumference (WC) is measured at the umbilicus using a 150 cm anthropometric steel measuring tape.
Measured: 6 weeks, week 1, week 2, week 4 and week 6
Changes in blood pressure (systolic blood pressure and diastolic blood pressure measured in mmHg)
Systolic and diastolic blood pressure (SBP and DBP) are measured twice after 2-5 minutes of patient seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Measured: 6 weeks, week 1, week 2, week 4 and week 6
Changes in ischemic reactive hyperemia (IRH measured in perfusion units)
The endothelial-dependent vasomotor functions will be measured as IRH by a Laser-Doppler linear Periflux 5000 flowmeter (Perimed AB, Järfälla, Stockholm, Sweden)
Measured: 6 weeks, week 1 and week 6
Changes in lipid plasmatic markers (total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A. All these lipid plasmatic markers will be measured in mg/dL)
Total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: 6 weeks, week 1 and week 6
Changes in glucose markers (glucose and insulin measured in mg/dL)
measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: 6 weeks, week 1 and week 6
Changes in oxidative markers (LDLox and Endogenous fat soluble antioxidants measured in mg/dL)
Plasma oxidized LDL measured by ELISA kit (Mercodia AB, Uppsala, Sweden). The analysis of fat-soluble vitamins (vitamin D, alpha-tocopherol, and carotenoids) will be carried out in whole blood with DBS cards. The determinations will be performed by ultra-performance liquid chromatography (UPLC) coupled to photodiode array (PDA) and tandem mass spectrometry (MS/MS) detectors.
Measured: 6 weeks, week 1 and week 6
Changes in inflammation markers (c-reactive protein and serum endothelin-1 measured in mg/dL)
Serum high sensitive C reactive measured by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). Serum endothelin type 1 measured by ELISA kits (R\&D Systems, Minneapolis, USA).
Measured: 6 weeks, week 1 and week 6
Changes in dietary compliance markers (Phenolic compounds and metabolites measured in mg/L in 24h urine samples)
will be analysed by UPLC-MS/MS as previously described.
Measured: 6 weeks, week 1 and week 6
Changes in faeces metabolites (Short Chain Fatty Acids, bile acids and sterols measured in mg/L in faeces samples)
will be performed by gas chromatography (GC).
Measured: 6 weeks, week 1 and week 6
Changes in fecal microbiota composition (relative abundance of the identified operational taxonomic units (OTUs) measured as % change from baseline)
will be studied by sequencing its whole genomic content. Illumina platform will be used to obtain the metagenomics and metatranscriptomics of each sample following previous protocols developed.
Measured: 6 weeks, week 1 and week 6
Changes in lipoprotein profile (number of LDL and HDL particles measured as % change from baseline)
Number of particles and size LDL and HDL measured by NMR technology, in a Vantera Clinical Analyzer (LipoScience Inc., Raleigh, NC, USA).
Measured: 6 weeks, week 1 and week 6
Changes in cholesterol efflux (measured as % change from baseline)
Cholesterol efflux measured by in vitro assays in Murine J-774A.1 macrophages labeled with TopFluor-Cholesterol, a fluorescent cholesterol probe in which the cholesterol molecule is linked to boron dipyrromethene difluoride (BODIPY) moiety (Avanti Polar Lipids, USA).
Measured: 6 weeks, week 1 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
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 High LDL-cholesterol LevelsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Lleida, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Rosa Sola, MD, PhD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795324
- Sponsor's protocol ID
- AppleCor
- Acronym
- AppleCor
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macia A, Romero MP, Pedret A, Sola R, Clifford MN, Rubio-Pique L. Assessment of human inter-individual variability of phloretin metabolites in urine after apple consumption. AppleCOR study. Food Funct. 2023 Nov 27;14(23):10387-10400. doi: 10.1039/d3fo02985a.
PubMed 37933196
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors: Innovation in Crop and Application to Health.
- ClinicalTrials.gov ID
- NCT03795324
- Acronym / sponsor ID
- AppleCor / AppleCor
- Conditions
- High LDL-cholesterol Levels
- Keywords
- Anthocyanins, apple, biofortification, cardiometabolic, LDL cholesterol, polyphenols
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Universitat de Lleida, Ministerio de Ciencia e Innovación, Spain
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 7 Jan 2019 (actual)
- 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.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins, and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
Detailed description
The worldwide high prevalence of cardiovascular disease (CVD) requires lifestyle changes and new dietary prevention strategies based on the increased intake of foods rich in bioactive compounds, as they are considered as key mediators in the improvement of CVD risk factors.
Regarding the health impact on anthocyanins in cardiometalic risk factors and CVD, it has been reported that the dietary intake of anthocyanidins, among other classes of flavonoids, is inversely associated with the risk of CVD in both European and US population. A recent systematic review of human randomized controlled trials assessing the impact of anthocyanins on CVD markers concluded that one of the main modulated outcomes is the decrease of serum LDLc. However, diet does not appear to be sufficient to guarantee the necessary intake to obtain the health benefits specified. Due to previous positive results, a new dietetic strategy based on biofortification to enhance the levels of phenolic compounds is proposed in the present project.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability of anthocyanins and its effect on cardiometabolic risk factors, in two different products with a similar phenolic and anthocyanin content: the redlove apple and an aronia drink.
Participants will be 120 free-living volunteers (men and women) with high LDL-cholesterol levels (LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl) who will be assigned to one of the three arms for 6-week period of dietary treatment. The design of the intervention study is controlled, parallel and randomized. The intervention will combine acute (post-prandial) and chronic effects.
The sample size was computed to be sufficient to detect differences between treatment groups regarding the evolution in time of LDL-cholesterol levels. Justification of chosen sample size is based on assuming a 0.50mmol/l (approximately 15%) post-intervention difference of LDL-cholesterol and a 0.72mmol/l Standard deviation (SD), with α=0.05 and 1-β=0.08 a minimum of 22 participants were required. However the sample size will be 40 participants for arm, in total 120 subjects.
For the acute study, the investigators have chosen n=10 subjects per arm according to the most studies that have addressed the metabolic effects of a postprandial intervention have been performed using a very similar number of subjects with statistically good quality results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Redlove Apple | Experimental | Other: Redlove Apple interventionRedlove Apple intervention This product is a biofortified cultivar apple with anthocyanins. |
| Green Apple | Experimental | Other: Green Apple interventionGreen Apple intervention This product is a common cultivar apple without anthocyanins. |
| Aronia Drink | Experimental | Other: Aronia drink interventionAronia drink intervention This product is an infusion of aronia fruit extract rich in anthocyanin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years old.
- LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl.
- Sign the informed consent provided before the initial screening visit.
Key exclusion criteria (16 listed)
- LDL-cholesterol levels ≤115 mg/dl and <190 mg/dl.
- Use of hypolipemiant treatment (drugs and functional foods), or hypoglucaemiant treatment.
- Having diabetes mellitus type 1 or type 2.
- BMI values ≥35kg/m2.
- Present triglycerides levels ≥350mg/dl.
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 |
|---|---|---|
| Redlove Apple interventionThe bioactive compounds present in this product are anthocyanins (50mg per 80g of product).It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized redlove apple. | Other | Redlove Apple |
| Green Apple interventionIt was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized green apple. | Other | Green Apple |
| Aronia drink interventionThe bioactive compounds present in this extract are anthocyanins (50mg per 1L of water).It was a 6 weeks nutritional intervention. Volunteers will drink 1L per day of an aronia drink | Other | Aronia Drink |
Primary outcome
Changes in serum LDL-cholesterol (measured in mg/dL)
Time frame: 6 weeks, week 1 and week 6
Serum lipids will be measured by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). Then, LDL-cholesterol will be alculated by the Friedewald formula.
15 secondary outcomes
Changes in parameters of body composition (weight measured in kg)
Time frame: 6 weeks, week 1, week 2, week 4 and week 6
Parameters of body composition (height measured in meters)
Time frame: 6 weeks, week 1
Changes in parameters of body composition (BMI measured in kg/m2)
Time frame: 6 weeks, week 1, week 2, week 4 and week 6
Changes in parameters of body composition (waist circumference measured in cm)
Time frame: 6 weeks, week 1, week 2, week 4 and week 6
Changes in blood pressure (systolic blood pressure and diastolic blood pressure measured in mmHg)
Time frame: 6 weeks, week 1, week 2, week 4 and week 6
Changes in ischemic reactive hyperemia (IRH measured in perfusion units)
Time frame: 6 weeks, week 1 and week 6
Changes in lipid plasmatic markers (total cholesterol, HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100 and Apo A. All these lipid plasmatic markers will be measured in mg/dL)
Time frame: 6 weeks, week 1 and week 6
Changes in glucose markers (glucose and insulin measured in mg/dL)
Time frame: 6 weeks, week 1 and week 6
Changes in oxidative markers (LDLox and Endogenous fat soluble antioxidants measured in mg/dL)
Time frame: 6 weeks, week 1 and week 6
Changes in inflammation markers (c-reactive protein and serum endothelin-1 measured in mg/dL)
Time frame: 6 weeks, week 1 and week 6
Changes in dietary compliance markers (Phenolic compounds and metabolites measured in mg/L in 24h urine samples)
Time frame: 6 weeks, week 1 and week 6
Changes in faeces metabolites (Short Chain Fatty Acids, bile acids and sterols measured in mg/L in faeces samples)
Time frame: 6 weeks, week 1 and week 6
Changes in fecal microbiota composition (relative abundance of the identified operational taxonomic units (OTUs) measured as % change from baseline)
Time frame: 6 weeks, week 1 and week 6
Changes in lipoprotein profile (number of LDL and HDL particles measured as % change from baseline)
Time frame: 6 weeks, week 1 and week 6
Changes in cholesterol efflux (measured as % change from baseline)
Time frame: 6 weeks, week 1 and week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Derived from this study: PubMed 37933196Macia A, Romero MP, Pedret A, Sola R, Clifford MN, Rubio-Pique L. Assessment of human inter-individual variability of phloretin metabolites in urine after apple consumption. AppleCOR study. Food Funct. 2023 Nov 27;14(23):10387-10400. doi: 10.1039/d3fo02985a.
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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.
Rosa Sola, MD, PhD principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Redlove Apple intervention, Green Apple intervention and Aronia drink intervention in people with High LDL-cholesterol Levels, run by University Rovira i Virgili at 1 site in Spain.
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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 7 Jan 2019. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Solà, Dr (636 944 723 ext. 0034, rosa.sola@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum LDL-cholesterol (measured in mg/dL) (time frame: 6 weeks, week 1 and week 6). 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 NCT03795324, 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 7 Jan 2019.