Clinical trial NCT01988389: Effect of Apples on cardioVascular Risk And Gut Health
Official title: Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Hypercholesterolemia
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Fondazione Edmund Mach di San Michele all'Adige
First posted: 2013-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 23
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Mildly hypercholesterolemic: TC\>5.2 and \<7.9 mmol/L
* BMI: 20-35
* Age: 23-69
* Normal liver and kidney function

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Changes in blood lipid levels
timeFrame: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period.
Secondary outcomes:
measure: Evaluation of endothelial function by using laser doppler iontophoresis (LDI)
timeFrame: Baseline and assessment at 8 weeks for each intervention arm.
measure: Changes in vascular stiffness by pulse wave analysis (PWA)
timeFrame: Baseline and assessment at 8 weeks for each intervention arm
measure: Changes in faecal bacterial population
timeFrame: Baseline and assessment at 8 weeks for each intervention arm
measure: Ambulatory blood pressure
timeFrame: Baseline and assessment at 8 weeks for each intervention arm
measure: Changes in inflammatory, endothelial function and oxidative stress markers
timeFrame: Baseline and assessment at 8 weeks for each intervention arm
measure: Changes in insulin resistance and gut hormones
timeFrame: Baseline and assessment at 8 weeks for each intervention arm
measure: Metabolomic analysis for the determination of the low molecular weight metabolite profiles in the biological fluids (blood, urine and faecal sample).
timeFrame: Baseline and assessment at 8 weeks for each intervention arm
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Julie A Lovegrove, BSc, PhD, RNutr
role: PRINCIPAL_INVESTIGATOR
affiliation: FEM-IASMA Research and Innovation centre
name: Kieran Tuohy, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.