Evidence map›Paper›PMID 29078780›Full record

Trial reportNutrition journal2017

The effect of an apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers on brachial artery flow-mediated vasodilatory function in volunteers with elevated blood pressure.

Maria Saarenhovi, Pia Salo, Mika Scheinin, Jussi Lehto, Zsófia Lovró, Kirsti Tiihonen, Markus J Lehtinen, Jouni Junnila, Oliver Hasselwander, Anneli Tarpila and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01690676 (The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01690676 phase2completednot on this map

The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects

TypeinterventionalSponsorDaniscoRan2012 to 2013Enrolled57ConditionsBorderline HypertensionArmsEpicatechin, Microcrystalline cellulose
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Maria SaarenhoviResearch Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland. marwen@utu.fi.ORCID http://orcid.org/0000-0002-2395-3491
Pia SaloResearch Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.
Mika ScheininClinical Research Services Turku (CRST), University of Turku, and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.
Jussi LehtoClinical Research Services Turku (CRST), University of Turku, and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.
Zsófia LovróClinical Research Services Turku (CRST), University of Turku, and Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland.
Kirsti TiihonenDuPont, Nutrition and Health, Kantvik, Finland.
Markus J LehtinenDuPont, Nutrition and Health, Kantvik, Finland.
Jouni Junnila4Pharma Ltd, Turku, Finland.
Oliver HasselwanderDuPont, Nutrition and Health, Reigate, UK.
Anneli TarpilaDuPont, Nutrition and Health, Kantvik, Finland.
Olli T RaitakariResearch Centre of Applied and Preventive Cardiovascular Medicine, University of Turku, Turku, Finland.
University of Turku · FIDuPont (Finland) · FIDuPont (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe primary aim of this study was to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves endothelium-dependent brachial artery flow-mediated vasodilatation (FMD) in volunteers with borderline hypertension. The secondary aim of the study was to test whether the investigational product would improve endothelium-independent nitrate-mediated vasodilatation (NMD).

methodsThis was a single centre, repeated-dose, double-blind, placebo-controlled, crossover study in 60 otherwise healthy subjects (26 men, 34 women; aged 40-65 years) with borderline hypertension (blood pressure 130-139/85-89 mmHg) or unmedicated mild hypertension (blood pressure 140-165/90-95 mmHg). The subjects were randomised to receive placebo or the apple polyphenol extract to provide a daily dose of 100 mg epicatechin for 4 weeks, followed by a four to five-week wash-out period, and then 4 weeks intake of the product that they did not receive during the first treatment period. FMD and NMD of the left brachial artery were investigated with ultrasonography at the start and end of both treatment periods, and the per cent increase of the arterial diameter (FMD% and NMD%) was calculated.

resultsWith the apple extract treatment, a significant acute improvement was detected in the mean change of maximum FMD% at the first visit 1.16 (p = 0.04, 95% CI: 0.04; 2.28), last visit 1.37 (p = 0.02, 95% CI: 0.22; 2.52) and for both visits combined 1.29 (p < 0.01, 95% CI: 0.40; 2.18). However, such improvement was not statistically significant when apple extract was compared with placebo. The overall long-term effect of apple extract on FMD% was not different from placebo. No statistically significant differences between the apple extract and placebo treatments were observed for endothelium-independent NMD.

conclusionsA significant acute improvement in maximum FMD% with apple extract administration was found. However, superiority of apple extract over placebo was not statistically significant in our study subjects with borderline hypertension or mild hypertension. The study raised no safety concerns regarding the daily administration of an apple polyphenol extract rich in epicatechin.

trial registrationThe trial is registered at http://clinicaltrials.gov (identifier: NCT01690676 ). Registered 25th May 2012.

Indexed as

VasodilationAdultAgedBrachial ArteryCatechinChlorogenic AcidCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodEndothelium, VascularFemaleFlavonoidsHumansHypertensionMaleMalusapple polyphenol extractCatechinChlorogenic Acidflavan-3-olFlavonoidsTanninsEndothelial functionEpicatechinFlavanol-3-olsFlavonoidsVasodilatory function

Identifiers

PMID29078780
PMCPMC5660451
OpenAlexW2765773612

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.