Plain English Summary
Background and study aims
Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. The incidence of CVD is increasing worldwide. Diets rich in fruits and vegetables are among the recommended lifestyle changes that decrease the risk of CVD. Blueberries are a rich source of anthocyanins that have been found to improve blood vessel function and protect against DNA damage. The aim of this study is to investigate the effect of a wild blueberry drink on blood vessel function and DNA damage in people with at least one risk factor for CVD.
Who can participate?
Men aged 40-60 with at least one risk factor for CVD (smoking, high blood pressure, high cholesterol or overweight)
What does the study involve?
Participants are randomly allocated to drink either a wild blueberry drink or a placebo drink (a similar drink but not containing the active ingredients) daily for 6 weeks. After a 6-week break participants then swap to the other drink for a further 6 weeks. Blood vessel function, DNA damage, and other factors such as blood pressure and blood glucose (sugar) and lipid (fat) levels, are measured before and after consuming the wild blueberry or placebo drinks for 6 weeks.
What are the possible benefits and risks of participating?
Drinking the wild blueberry drink may improve blood vessel function and protect against DNA damage. No risks are expected.
Where is the study run from?
University of Milan (Italy)
When is the study starting and how long is it expected to run for?
October 2009 to May 2010
Who is funding the study?
Cariplo Foundation (Italy)
Who is the main contact?
Prof. Marisa Porrini
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Use of biosensors within a multidisciplinary approach for the study of degenerative disease prevention through diet
Acronym
WBH1
Study hypothesis
Oxidative stress is believed to be involved in vascular function, oxidative damage and inflammation in cardiovascular (CVD) diseases. Subjects with CVD risk factors such as: smoking, pre-hypertension, high serum cholesterol, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, high triglycerides and overweight, constitute a good model to examine the protective role of an anthocyanin (ACN) rich diet in this population group. We hypothesize that a diet enriched with wild blueberries could improve endothelial function (i.e. improved peripheral arterial tone) and cell protection against oxidative damage (e.g. DNA damage) by providing ACNs and related metabolites able to affect directly or indirectly such functions. Moreover, the regular intake of these compounds could also modulate other markers related to oxidative stress and the inflammatory process.
Ethics approval
Ethics Committee of the University of Milan, 10/01/2008
Study design
Randomized repeated measures crossover design
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Risk factors for cardiovascular disease
Intervention
Participants were randomized in a cross-over design and received a wild blueberry (25 g freeze-dried wild blueberry providing 375 mg of anthocyanins, in 250 mL of water) or a placebo drink (sensory characteristics similar to the wild blueberry drink, with the same amount of sugars but without polyphenols/anthocyanins) for six weeks each. The two experimental periods were separated by a six week wash-out period.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The following outcomes were measured at the beginning and at the end of each experimental period:
1. The improvement of peripheral vascular function (measured by a non-invasive pletismographic method)
2. The reduction of endogenous oxidized DNA bases and the resistance to H2O2-induced DNA damage (evaluated in blood mononuclear cells by Comet assay)
Secondary outcome measures
The following outcomes were measured at the beginning and at the end of each experimental period:
1. Body mass index (BMI)
2. Nutritional biomarkers [anthocyanins (ACNs), vitamin C, folate, vitamin B12, glutathione (GSH/ GSSG)]
3. Changes in blood pressure (diastolic and systolic blood pressure) and markers of endothelial function: [soluble vascular adhesion molecule concentration (sVCAM-1), total nitric oxide (NO)].
4. Changes in glucose and lipid profile (triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol)
5. Changes in markers of inflammation [C-reactive protein (CRP), tumor necrosis factor alpha (TNF-¦Á), interleukin-6 (IL-6)]
6. Modulation of cell DNA repair activity and enzyme activities [glutathione-S-transferase (GST)-activity, superoxide dismutase (SOD) and glutathione peroxidase (GSH-px)]
7. Changes in serum creatinine, S-aspartate aminotransferase, S-alanine aminotransferase and S-gamma glutamiltransferase
Overall trial start date
03/10/2009
Overall trial end date
15/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Wish to participate
2. Male subjects
3. Healthy subjects with at least one risk factor for cardiovascular disease such as: smoking (more than 10 cigarettes/day), pre-hypertension (systolic pressure 120-139 mm Hg and diastolic pressure between 80-89 mm Hg), high serum cholesterol (more than 200 mg/dl), low HDL cholesterol (lower than 40 mg/dl), high LDL cholesterol (more than 130 mg/dl), high triglycerides (more than 150 mg/dl) and overweight body mass index (BMI) more than 25)
4. Signed informed consent
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
30 subjects were screened. 20 subjects were finally selected for participation in the study.
Participant exclusion criteria
1. Individuals with secondary hypertension or obesity (BMI > 30)
2. Diabetes, renal insufficiency, known food allergies, chronic constipation, diarrhea or any other gastrointestinal problem, or diseases
3. Use of any drugs, supplements, specific prebiotics or prebiotics or medications at least one month before the beginning of the experiment
4. Volunteers who did not eat fruits and vegetables
5. Difference in dietary habits in particular for food rich in antioxidant compounds: high (> 5 portions/day) or low (<2 portions/day) intake of fruit and vegetables
6. Habitual alcohol consumption (> 3 drinks per week)
7. Vegetarian, vegan or macrobiotic
8. Subjects with specific aversion to blueberries or their products
Recruitment start date
03/10/2009
Recruitment end date
15/05/2010
Locations
Countries of recruitment
Italy
Trial participating centre
University of Milan
Milan
20133
Italy
Sponsor information
Organisation
University of Milan (Italy)
Sponsor details
c/o Prof. Marisa Porrini
Faculty of Agriculture
DiSTAM-Department of Food Science and Microbiology Division of Nutrition
Via G. Celoria 2
Milan
20133
Italy
+39 02 503 16720
marisa.porrini@unimi.it
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Cariplo Foundation (Italy) - (Research grant 2007-5810)
Alternative name(s)
Cariplo Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Italy
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22733001
Publication citations
-
Results
Riso P, Klimis-Zacas D, Del Bo' C, Martini D, Campolo J, Vendrame S, Møller P, Loft S, De Maria R, Porrini M, Effect of a wild blueberry (Vaccinium angustifolium) drink intervention on markers of oxidative stress, inflammation and endothelial function in humans with cardiovascular risk factors., Eur J Nutr, 2013, 52, 3, 949-961, doi: 10.1007/s00394-012-0402-9.