Endothelial Dysfunction Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Clinical Trial on the Metabolic and Vascular Effects of a Dietary Supplementation With Apple Polyphenols in Overweight Subjects
Verified date | January 2024 |
Source | University of Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Apple polyphenols are mostly acknowledged for their hypoglycaemic properties, but represent an apple active fraction with many pharmacological functions. The study aim was to examine their effect on uricemia and endothelial function in a sample of overweight subjects. This was a two-phases study. The in vitro experiment aimed to evaluate the apple polyphenols' ability to lower uric acid in comparison with allopurinol. The in vivo study consisted in a randomized, double-blind, parallel placebo-controlled clinical trial involving 62 overweight volunteers with suboptimal values of fasting plasma glucose (100 mg/dL≤FPG≤125 mg/dL), randomized to be treated with 300 mg apple polyphenols or placebo for 8 weeks.
Status | Completed |
Enrollment | 62 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Body mass index (BMI)>25 kg/m2 - Fasting plasma glucose 100 mg/dL = FPG = 125 mg/dL Exclusion Criteria: - Patients with obesity (body mass index [BMI] <30 Kg/m2) - diabetes mellitus - personal history of atherosclerosis-related cardiovascular diseases (coronary artery disease - cerebrovascular disease - ultrasound diagnosed carotid atherosclerosis) - absorption disease - myopathy - renal failure or chronic liver disease - serious or invalidating other diseases reducing the subjects' ability to comply with the full protocol were excluded from the study as well as subjects with a known apple intolerance. |
Country | Name | City | State |
---|---|---|---|
Italy | S. Orsola-Malpighi University Hospital | Bologna |
Lead Sponsor | Collaborator |
---|---|
University of Bologna |
Italy,
Cicero AFG, Caliceti C, Fogacci F, Giovannini M, Calabria D, Colletti A, Veronesi M, Roda A, Borghi C. Effect of apple polyphenols on vascular oxidative stress and endothelium function: a translational study. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial function | Change in arterial diameter after ischemic stimulus | 8 week |
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