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Anti-inflammatory activity of strawberries: a human intervention trial

Anti-inflammatory activity of strawberries: a human intervention trial - Strawberry trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34765
Enrollment
40
Registered
2010-03-31
Start date
2010-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

chronic inflammation endothelial dysfunction

Interventions

The intervention period will be 2 weeks, with 20 patients consuming 400 gram strawberries as 2 smoothies per day, and 20 patients consuming 2 bottles of 200 ml of isocaloric (compared to the smoothi

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Glucose tolerance and insulin sensitivity and blood pressure will also be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)