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Effect of a Polyphenol Rich Diet on Vascular and Platelet Function

Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01319786
Acronym
PPhIT
Enrollment
104
Registered
2011-03-22
Start date
2011-01-31
Completion date
2015-08-31
Last updated
2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Microvascular function

Brief summary

Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. The investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. A total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). They will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study. Assessment of microvascular and platelet function will be undertaken before and after consuming this diet. Improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. This study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.

Interventions

OTHERTwo portions of fruit and vegetables per day (excluding berries and dark chocolate)

Two portions of fruit and vegetables per day (excluding berries and dark chocolate)

OTHERSix portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.

Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.

Sponsors

Belfast Health and Social Care Trust
CollaboratorOTHER
Queen's University, Belfast
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age 40-65 years old * Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg

Exclusion criteria

* diabetes mellitus * an acute coronary syndrome or transient ischaemic attack within the past 3 months * special dietary requirements, food sensitivities or vegetarian/vegan diet by choice * oral anticoagulation therapy * body mass index greater than 35kg/m2 * excessive alcohol consumption (defined as \> 28 units/week in men and 21 units/week in women) * fasting triglyceride concentration \> 4 mmol/l * pregnancy/lactation * taking antioxidant supplements * medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements

Design outcomes

Primary

MeasureTime frameDescription
Vascular functionMeasured at weeks 4 and 12Pharmacological provocation of endothelium-dependent vasomotion.

Secondary

MeasureTime frame
Platelet function, biomarkers of cardiovascular risk and heart rate variabilityMeasured at weeks 0, 4 and 12

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026