Effect of Apples on cardioVascular Risk And Gut Health (AVAG)
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ClinicalTrials.gov Identifier: NCT01988389 |
Recruitment Status :
Completed
First Posted : November 20, 2013
Last Update Posted : March 9, 2015
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Sponsor:
University of Reading
Collaborator:
Fondazione Edmund Mach di San Michele all'Adige
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
Tracking Information | |||||||
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First Submitted Date ICMJE | October 10, 2013 | ||||||
First Posted Date ICMJE | November 20, 2013 | ||||||
Last Update Posted Date | March 9, 2015 | ||||||
Study Start Date ICMJE | September 2013 | ||||||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Changes in blood lipid levels [ Time Frame: Baseline and assessment at 8 weeks for each intervention arm including a 4 week wash out period. ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Effect of Apples on cardioVascular Risk And Gut Health | ||||||
Official Title ICMJE | Effect of Apples Consumption on Blood Lipid Levels,Vascular Function and Gut Health in Moderate Hypercholesterolemic Subjects | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Mild Hypercholesterolemia | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Koutsos A, Riccadonna S, Ulaszewska MM, Franceschi P, Trošt 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | November 2014 | ||||||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 23 Years to 69 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01988389 | ||||||
Other Study ID Numbers ICMJE | 13/22 University of Reading |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Julie Lovegrove, University of Reading | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | University of Reading | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Fondazione Edmund Mach di San Michele all'Adige | ||||||
Investigators ICMJE |
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PRS Account | University of Reading | ||||||
Verification Date | March 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |