Anti-inflammatory activity of strawberries: a human intervention trial

Completed

Conditions: chronic inflammation
endothelial dysfunction
10012653
10018424

Registration Number: NL-OMON34765

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Patients should:
- be aged between 40 and 70 years, both males and females
- be diagnosed for the metabolic syndrome i.e. have a waist circumference > 94 cm for men, and > 80 cm for women and have a fasting glucose > 100 mg/dl (5,5 mmol/l) and one of the following other criteria: triglycerides > 150 mg/dl, or treatment for this lipid abnormality; HDL cholesterol < 40 mg/dl for men, or < 50 mg/dl for women, or treatment; blood pressure systolic > 130 mg Hg, diastolic > 85 mm Hg, or treatment or previously diagnosed hypertension
- be diagnosed or treated for type 2 diabetes, but not use insulin

Exclusion Criteria

- insulin therapy
- previous allergic or hypersensitivity reactions for strawberries
- therapy with anti-inflammatory medication such as ibuprofen, naproxen, paracetamol, corticosteroids
- therapy with anti-coagulants such as acenocoumarol
- liver or kidney diseases
- acute infection less than 2 weeks ago
- malignancy or treated for a malignant disease < 6 months before the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Markers of endothelial function, inflammation and oxidative stress will be<br /><br>measured after an oral glucose tolerance test (OGTT). Measurements done at t=2<br /><br>h after glucose consumption will be compared to baseline values (t=0) values.<br /><br>The effect of the intervention will be measured on day 16 of the study, the<br /><br>second day after the last strawberry consumptiion, to exclude acute effects.<br /><br>The estimated outcome is a 25% reduction in the OGTT-induced inflammatory gene<br /><br>transcription.</p><br>

Secondary Outcome Measures