Overweight patients Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants are randomized by sealed envelope block method:
1. Study medication (VERUM) capsule composition: pomegranate extract 163 mg, chitin-glucan 375 mg, siliciumdioxide 18 mg, magnesium stearat
Sponsors
KitoZyme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female 2. Aged at least 18 years 3. Caucasian type 4. 25<BMI <35 ± 5% 5. Stable patient’s weight ± 5% for at least 3 last months and patient’s agreement not to change food habits during the study 6. Menopausal women without or with HRT with a stable rate for at least 3 months 7. Able to understand and to give consent 8. Compliant with treatment
Exclusion criteria
Exclusion criteria: 1. Current cancer treatment 2. Diabetes 3. Severe intestinal problems 4. Autoimmune or chronic inflammatory diseases 5. Unintentional weight loss (> 10% of body weight) during the previous 6 months 6. Particular nutritional practice (vegetarians, vegans, high consumption of fiber) 7. Intake of food supplements 8. History of eating disorders (anorexia, bulimia) 9. Dieting at the time of inclusion 10. Underwent bariatric surgery 11. Consumption in the preceding 6 weeks of antibiotics or probiotics 12. Pregnancy, breastfeeding 13. Active smoker or ex-smoker for less than 2 years 14. Food allergy to one of the components of the supplement 15. Participation in another clinical study at the time of inclusion 16. Usually taking medication: anti-inflammatory drugs, corticosteroids, antiepileptics, neuroleptics, laxatives, antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood collection with blood analysis at V0, V1, V3, V4: 1.1. Inflammatory parameters at V0, V1, V3, V4: 1.1.1. C-reactive protein high-sensitivity (hsCRP), µg/ml, measured using turbidimetric method 1.1.2. Interleukin 6, pg/ml, measured using ELISA 1.1.3. Interleukin 8, pg/ml , measured using ELISA 1.1.4. Interleukin 10, µmol/l, measured using ELISA 1.1.5. Tumor necrosis factor a, pg/ml, measured using ELISA 1.1.6. Monocyte chemotactic protein 1, MCP1, pg/ml, measured using ELISA 1.2 Parameters of oxidative and endothelial function at V0, V1, V3, V4: 1.2.1. Vitamin A, mg/L, measured using UPLC 1.2.2. Vitamin E, mg/L, measured using UPLC 1.2.3. Vitamin C, mg/l, measured using HPLC 1.2.4. Coenzyme Q10, µg/l, measured using HPLC 1.2.5 ß-carotene, ng/ml, measured using HPLC 1.2.6. Superoxide dismutase (SOD), U/ml, measured using enzyme assay 1.2.7. Glutathione peroxidase (GPX), U/ml, measured using spectrophotometry 1.2.8. Soluble vascular adhesion molecule 1 (sVCAM 1), ng/ml, measured using ELISA 1.2.9. Soluble intercellular adhesion molecule 1 (sICAM 1), ng/ml, measured using ELISA 1.2.10. Asymmetric dimethylarginine (ADMA), µmol/l, measured using ELISA 1.2.11. Cluster of differentiation 40 ligand (CD40-L), pg/ml, measured using ELISA 1.3. Lipid parameters at V0, V1, V3, V4: 1.3.1. Cholesterol, mg/dl, measured using reflectometry 1.3.2. High density lipoprotein (HDL), mg/dl, measured using reflectometry 1.3.3. Low density lipoprotein (LDL), mg/dl, measured using spectrophotometry 1.3.4. Triglycerides, mg/dl, measured using reflectometry 1.3.5. Lipoprotein a (LPa), g/l, measured using nephelometry 1.3.6. Apolipoprotein A1 (ApoA1), g/l, measured using nephelometry 1.3.7. Apolipoprotein B (ApoB), g/l, measured using nephelometry 1.3.8. Small density low density lipoprotein (Sd-LDL), nmol/ml, measured using ELISA 1.3.9. Anti-oxidized low density lipoprotein antibodies (anti ox-LDL ab), measured using ELISA 2. Endothelial function assessed by ultrasound examinati | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood collection with confounding parameters analysis at V0, V1, V3, V4: 1.1. Glycaemia, mg/dl, measured using reflectometry 1.2. Glycated hemoglobin A1c (HbA1c), %, measured using chromatography 1.3. Glutamic oxaloacetic transaminase (GOT), UI/L, measured using enzyme assay 1.4. Glutamic-pyruvic transaminase (GPT), UI/L, measured using enzyme assay 1.5. Gamma-glutamic transaminase (GGT), UI/L, measured using enzyme assay 1.6. Iron, µg/dl, measured using reflectometry 1.7. Albumin (ALB), g/l, measured using reflectometry 1.8. Ferritin, µg/l, measured using immunoassay 1.9. Magnesium, mmol/l, measured using reflectometry 1.10. Uric acid, mg/dl, measured using reflectometry 1.11 Creatinine (CRS), mg/dl, measured using enzyme assay 2. Collection of feces for intestinal microbiota analysis (V0, V3) during randomization and at the end of treatment 3. Assessment of nutritional status (via questionnaire) and bioelectrical impedance analysis at V0, V1, V2, V3, V4: 3.1. Height, m 3.2. Weight, kg 3.3. Waist circumference, cm 3.4. Abdominal diameter, cm 3.5. Fat, % 3.6. Fat, kg 3.7. Body mass index (BMI) 3.8. Waist/hip ratio | — |
Countries
Belgium
Outcome results
None listed