Ireland
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Active, not recruiting Not applicable

Markers of Oxidative Stress in Inflammatory Bowel Diseases: Risk Factors and Implications for a Dietetic Approach

NCT04513015 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2019-12-15
Last updated
2024-12-09

Condition(s) studied

Inflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Antioxidant dietNormal dietetic scheme

Antioxidant diet: The "antioxidant diet" will include the principal antioxidant molecules/nutrients previously shown to be beneficial in IBD: Flavonoids, particularly resveratrol and curcumin; Olive oil; Glutathione, Vitamins A, C, E; Carotenoids; Selenium and Omega 3 Fatty Acids (PUFAs). The daily amount of these substances will be calculated following the published evidence, whether these amounts will not be achievable by a standard diet, a supplementary formulation will be proposed.

Normal dietetic scheme: Isocaloric, normolipidic diet for age and sex

Study summary

Inflammatory bowel disease (IBD), including Crohn's disease (CD), Ulcerative Colitis (UC) and IBD-unclassified (IBD-U) is a chronic inflammatory intestinal disorders that affect both children and adults. Patients with IBD can present with severe gastrointestinal symptoms, require frequent hospitalizations, expensive medical treatments and can develop invalidating complications requiring surgery. The incidence of IBD is increasing worldwide. The pathogenesis is multifactorial with immunological, environmental and genetic factors contributing to the disease. There is evidence that oxidative stress (OS) imbalance is involved in IBD onset and evolution, although the exact contribution to the pathogenes is unclear. An antioxidant dietetic approach is promising as an adjunctive treatment of IBD. The main aims of this project are to characterize the OS imbalance in IBD in relation to disease's features and to genetic factors and to evaluate the efficacy of an antioxidant dietetic treatment

Eligibility

Sex
ALL
Min age
6 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: \- Diagnosis of IBD Exclusion Criteria: * permanent stoma * cancer * cardiovascular disease * ischemic disease * Alzheimer's disease * type 2 diabetes

Primary outcome measure(s)

  • Blood levels of ROS and glutathione in patients with IBD and controls — Baseline
    Blood levels of ROS will be determined by cytofluorimetry, blood levels of glutathione by spectrofluorimetry
  • Total antioxidant capacity (Trolox equivalent and ferrous equivalent) in patients with IBD and controls — Baseline
    Trolox equivalent will be assessed by antioxidant assay Kit, ferrous equivalent instead wille require a manual assessment.
  • Antioxidant enzymes pattern (GST, SOD, GPxs, GR enzyme levels, activity and transcripts) in patients with IBD and controls — Baseline
    Spectrophotometer will be used to assess enzyme levels and activity, cDNA kit to determine enzyme transcripts.
  • Plasma hydroperoxides and thiobarbituric acid reactive species in patients with IBD and controls — Baseline
    Plasma hydroperoxides will be detected by LPO ELISA kit, thiobarbituric acid reactive species by TBARS assay kit.
  • Urine oxidized guanines (8-OHdG, 8-OHG e guanosine) levels in patients with IBD and controls — Baseline
    DNA/RNA oxydate damage kit will be used to study urine oxidized guanines levels.

Trial sites (2)

FacilityCityRegionStatus
SOD Clinica Pediatrica, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona Italy
SOD Clinica di Gastroenterologia, Epatologia ed Endoscopia Digestiva, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04513015 on ClinicalTrials.gov ↗ ← All trials in Italy