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Bioactives Lead to Enhanced Disease defence

Combination chemoprevention of complex mixtures of fruits and vegetables

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21522
Enrollment
200
Registered
2020-04-15
Start date
2019-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chronic diseases: cancer, cardiovascular disease, type II diabetes

Interventions

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion 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 - Known allergies for oats and/or rice flour - 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:lymphocytes will be challenged ex-vivo to hydrogen peroxide which is able to generate oxygen radicals. These oxygen radicals are known to be able to damage our DNA, either by means of directly inducing strand breaks or by means of adduct formation. The amount of DNA strand breaks in the DNA can be measured by means of the alkaline Comet assay; - The level of oxidative stress parameters: To evaluate the effect of the different intervention on the level of oxidative stress, the antioxidant capacity of blood plasma will be measured by means of the Trolox Equivalent Antioxidant Capacity (TEAC) assay, and the levels of ROS will be measured by electron spin resonance (ESR). Furthermore, the level of excretion of 8-iso-prostaglandin F2 in urine as marker for lipid peroxidation will be measure; - Cardiovascular risk parameter: changes in microcirculation. A promising new biomarker for cardiovascular disease risk is a change in the retinal microvasculature. Therefore, diameters of retinal vessels will be measured in a photographed image of the fundus of the right eye in order to produce summary indices representing the mean retinal arteriole calibre (CRAE) and mean retinal venule calibre (CRVE). - Whole genome gene expression analyses. In order to gain more insight into the molecular mechanisms, whole genome gene expression analyses will be carried out in whole blood using 1-color microarray analyses (Agilent 8 × 60 K Whole Human Genome microarrays). - Evaluation of the prevalence of different polymorphisms. In order to evaluate whether subgroups with different genetic characteristics respond differently on the consumption of different MiFood products the impact of different polymorphisms related to disease risk (cancer, diabetes type II, cardiovascular disease) and metabolisms of bioactive compounds on the different phenotypic markers and gene expression changes will be established.

Secondary

MeasureTime frame
- Bioavailability of different phytochemicals in the different interventions, plasma levels of e.g. vitamin C, quercetine, alpha-carotene, beta-carotene, lutein, lycopene, resveratrol, alpha-tocopherol, cryptoxanthin, glucosinulates, and total polyphenols will be measured by means of high-performance liquid chromatography (HPLC). - Composition of the different white blood cells by means of a white blood cell count. - OPTIONAL Phenotypical markers:In case the study identifies processes on gene expression level related to lipid metabolism, immune response and/or glucose homeostasis, additional measurements of phenotypic markers will be carried which are associated with the identified biological processes and include e.g.: - 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-alpha, 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).

Contacts

Public ContactSimone van Breda

Maastricht University

s.vanbreda@maastrichtuniversity.nl0031433882127

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)