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Het effect van voedingsproducten met verschillende combinaties van groenten en fruit op de gezondheid van de mens The effect of food products containing different combinations of vegetables and fruits on human health

Combination chemoprevention of complex mixtures of fruits and vegetables

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23386
Enrollment
200
Registered
2018-10-18
Start date
2019-01-01
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

Combination chemoprevention, chronic diseases, cancer, diabetes, cardiovascular disease,molecular mechanisms, synergisms, Combinatie chemopreventie, chronische ziekten, kanker, diabetes, hartvaat ziekten, moleculaire mechanismen, synergie

Interventions

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Healthy men or women with a Body Mass Index (BMI) between 18.5 and 27; - Between 18-60 years old.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Alcohol abuse up to 6 months before participation in this research, i.e. more than 4 drinks on any single day and more than 14 drinks per week for men and more than 3 drinks on any single day and more than 7 drinks per week for women; - Current presence of any diseases related to the gastrointestinal tract, kidney, liver, heart or lungs; - Current presence of type I or type II diabetes; - Current presence of symptoms related to diseases of the gastrointestinal tract, i.e. vomiting, diarrhea or constipation, and altered stool, such as blood in stool; - Current presence of diseases related to the endocrine or metabolic system; - Current presence of anemia; - HIV infection or hepatitis; - Use of antibiotics and other medication (except contraceptives) over the last 3 months; - Use of dietary supplements during the 3 months before start of the study; - Known allergies for fruits and/or vegetables - Current smokers and ex-smokers who stopped during the 3 months before start of the study; - Vegetarians and vegans; - Pregnant women; - Sportsmen and sportswomen who are physically active for more than 8 hours per week - Participants of other intervention studies during this intervention period.

Design outcomes

Primary

MeasureTime frame
-The level of oxidative DNA damage in ex-vivo treated lymphocytes -Oxidative stress parameters -Cardiovascular risk parameter: changes in microcirculation -Whole genome gene expression analyses -Evaluation of the prevalence of different polymorphisms

Secondary

MeasureTime frame
Optional parameters: The level of different plasma lipid levels such as cholesterol by measuring total cholesterol, high density lipoproteins (HDL), and low density lipoproteins (LDL), and triglycerides using standard kits; - The level of plasma homocysteine by means of ELISA; - Platelet activation by measuring platelet factor 4 and P-selectin in plasma using ELISA; - Immune response markers, like TNF-, interleukin-6, and C-reactive protein, using ELISA; - The level of fasting glucose and insulin levels in plasma in order to quantify insulin resistance and beta-cell function by means of Homeostatic model assessment (HOMA model). - bioavailability of different phytochemicals in the different interventions measured in plasma - white blood cell count

Contacts

Public ContactS.G.J. van Breda

P.O. Box 616, School for Oncology and Developmental, Department of Toxicogenomics, Maastricht University Medical Centre +

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)