Immunomodulation
Conditions
Keywords
chokeberry, Nutridrink, immunomodulation, tumor resection
Brief summary
The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting the recovery of oncology patients undergoing surgical resection of tumours.
Detailed description
Oncology patients undergoing the procedure are exposed to various postoperative complications. Nutridrink with a mixture of extracts with anti-inflammatory and antioxidative properties aims to provide the patient with essential nutrients and bioactive substances that can reduce the inflammatory state, protect cells from oxidative damage, and decrease the risk of complications while supporting tissue healing processes after the surgical procedure. The study group are oncology patients undergoing surgical resection of gastrointestinal tumour. During the study, the effects of the mixture on levels of oxidative stress and inflammation markers will be assessed, as well as the subjective evaluation of patients' quality of life and well-being after surgical surgical tumor resection.
Interventions
DIETARY_SUPPLEMENTNutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
2 times a day
DIETARY_SUPPLEMENTNutridrink Skin Repair
2 times a day
Sponsors
AronPharma Sp. z o. o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women and men, 18-80 years old * Patients diagnosed with resectable gastrointestinal tract cancer undergo the resection procedure no later than one month after being enrolled in the study * Signed informed consent
Exclusion criteria
* Intake of supplements containing plant extracts, polyphenols or anthocyanins * Participation in another clinical trial * Inability to consume the investigational product in liquid form as medication/placebo * Women who are pregnant, planning to become pregnant during the study or breastfeeding * Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation * Hypersensitivity/allergy to any of the ingredient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOD level | Baseline, 3 weeks, 6 weeks | Comparison of SOD level |
| GSH level | Baseline, 3 weeks, 6 weeks | Comparison of GSH level |
| IL-6 level | Baseline, 3 weeks, 6 weeks | Comparison of IL-6 level |
| IL-8 level | Baseline, 3 weeks, 6 weeks | Comparison of IL-8 level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' quality of life | Baseline, 3 weeks, 6 weeks | Subjective assessment of patients' quality of life after surgical resection of the tumor (questionnaire). Higher scores mean a better outcome. |
Countries
Poland
Outcome results
None listed