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Trial record 41 of 84 for:    catechin

The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk (FLAVASCULAR Study) (FLAVASCULAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02013856
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Quadram Institute Bioscience

Brief Summary:
Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.

Condition or disease Intervention/treatment Phase
Blood Pressure Dietary Supplement: Low Epicatechin and procyanidin Dietary Supplement: High Epicatechin and procyanidin Dietary Supplement: High procyanidin Dietary Supplement: Placebo Not Applicable

Detailed Description:
This study is a single arm randomized, 4-phase crossover design.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk
Study Start Date : July 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Low Epicatechin and procyanidin
Low epicatechin and procyanidin doses
Dietary Supplement: Low Epicatechin and procyanidin
70 mg epicatechin and 65 mg procyanidins once daily for 28 days

Experimental: High Epicatechin and procyanidin
High epicatechin and procyanidin doses
Dietary Supplement: High Epicatechin and procyanidin
140 mg epicatechin and 130 mg procyanidins once daily for 28 days

Experimental: High Procyanidin
High procyanidin only
Dietary Supplement: High procyanidin
No epicatechin and 130 mg procyanidins once daily for 28 days

Placebo Comparator: Placebo
No epicatechin and procyanidin
Dietary Supplement: Placebo
Placebo control once daily for 28 days




Primary Outcome Measures :
  1. Changes in systolic blood pressure from baseline [ Time Frame: Baseline, 2 hours and 4 weeks ]

Secondary Outcome Measures :
  1. Changes in plasma lipid profile from baseline [ Time Frame: Baseline and 4 weeks ]
  2. Change in plasma endothelin-1 from baseline [ Time Frame: Baseline and 4 weeks ]
  3. Changes in plasma nitric oxide metabolites from baseline [ Time Frame: Baseline, 2 hours and 4 weeks ]
  4. Changes in blood glucose from baseline [ Time Frame: Baseline and 4 weeks ]
  5. Changes in pulse wave velocity from baseline [ Time Frame: Baseline, 2 hours and 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women ≥ 50 years of age
  • Systolic blood pressure 130 - 159 mmHg

Exclusion Criteria:

  • History of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease
  • Kidney or liver disease/problems
  • Diabetes
  • Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
  • Prescribed anti-hypertensive medication
  • HRT (unless the participant has used the therapy for ≥ 6 months)
  • Lipid lowering therapies e.g. statins
  • Other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis)
  • Current smoker (or stopped for less than 3 months)
  • Throat surgery or neck injury
  • Allergy to apples
  • Consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (All other supplements will be assessed on a case by case basis)
  • Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
  • Parallel participation in another research project which involves dietary intervention
  • Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml.
  • Has donated or intends to donate blood within 16 weeks prior to or during the study period.
  • Depressed or elevated blood pressure measurements (<90/50 or 95/55 if symptomatic or >160/100 (mmHg)) during the course of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013856


Locations
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United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Quadram Institute Bioscience
Investigators
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Principal Investigator: Paul Dr Kroon, PhD Quadram Institute Bioscience

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Quadram Institute Bioscience
ClinicalTrials.gov Identifier: NCT02013856     History of Changes
Other Study ID Numbers: IFR05/2013
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2015

Keywords provided by Quadram Institute Bioscience:
Blood pressure
Flavanols
Cardiovascular disease

Additional relevant MeSH terms:
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Cardiovascular Diseases
Procyanidin
Proanthocyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents