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| ID | Type | Description | Link |
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| University of Reading |
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| Name | Class |
|---|---|
| Fondazione Edmund Mach di San Michele all'Adige | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whole apples | Experimental | Subjects are asked to consume 2 apples a day for 8 weeks in addition to their habitual diet |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole apples (WA) | Dietary Supplement |
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| apple juice (AJ) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood lipid levels | Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of endothelial function by using laser doppler iontophoresis (LDI) | Baseline and assessment at 8 weeks for each intervention arm. | |
| Changes in vascular stiffness by pulse wave analysis (PWA) | Baseline and assessment at 8 weeks for each intervention arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Lovegrove, BSc, PhD, RNutr | University of Reading | Principal Investigator |
| Kieran Tuohy, Dr | FEM-IASMA Research and Innovation centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Nutritional Sciences, University of Reading | Reading | Berkshire | RG6 6AP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31840162 | Derived | 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. |
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| Changes in faecal bacterial population | 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 | Baseline and assessment at 8 weeks for each intervention arm |
| Changes in inflammatory, endothelial function and oxidative stress markers | Baseline and assessment at 8 weeks for each intervention arm |
| Changes in insulin resistance and gut hormones | 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). | Baseline and assessment at 8 weeks for each intervention arm |