Effect of Apple Polyphenols on Vascular Oxidative Stress and Endothelium Function Study (APP trial_2016)

NCT03053986 | Completed

• 1 other identifier: APP trial_2016
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Change in arterial diameter after ischemic stimulus

  8 week

Study Arms (2)

Apple polyphenols

ACTIVE COMPARATOR

White capsule containing 300 mg of apple extract (Malus Domestica) with glycosilated polyphenols (≥90%) including glycosilated phloritzin (15-30%), chlorogenic acid (10-25%) and quercetin (15-25%)

Dietary Supplement: Apple polyphenols

Placebo

PLACEBO COMPARATOR

Indistinguishable capsules with similar dimension, colour, odour and taste

Other: Placebo

Interventions

Apple polyphenols DIETARY_SUPPLEMENT

1 tablet per day at evening before sleeping

Apple polyphenols

Placebo OTHER

1 tablet per day at evening before sleeping

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI)\>25 kg/m2
• Fasting plasma glucose 100 mg/dL ≤ FPG ≤ 125 mg/dL

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, 40038, Italy

Location

Related Publications (1)

• 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: 10.1002/mnfr.201700373. Epub 2017 Sep 1.

  PMID: 28755406 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 15, 2017
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

IT (1)