Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors. (AppleCor)

University Rovira i Virgili

Status and phase: Unknown; Phase 2

Conditions: High LDL-cholesterol Levels

Treatments: Other: Redlove Apple intervention; Other: Green Apple intervention; Other: Aronia drink intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03795324

AppleCor

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Redlove Apple

Experimental group

Description:

Redlove Apple intervention This product is a biofortified cultivar apple with anthocyanins.

Treatment:

Other: Redlove Apple intervention

Green Apple

Experimental group

Description:

Green Apple intervention This product is a common cultivar apple without anthocyanins.

Treatment:

Other: Green Apple intervention

Aronia Drink

Experimental group

Description:

Aronia drink intervention This product is an infusion of aronia fruit extract rich in anthocyanin.

Treatment:

Other: Aronia drink intervention