Reduction in release of inflammation markers Signs and Symptoms
Conditions
Interventions
A total of 40 subjects will be randomised into one of four treatment arms each containing 10 subjects. Subjects will be randomly assigned to one of the eight study arm treatment sequences (4 treatment
Sponsors
Sibelius Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy young adults aged 18 - 35 years 2. Willing to participate and signed informed consent 3. Ability to understand the background and the purpose of the study 4. Willing to comply with the protocol and the study specific limitations 5. Body Mass Index between 18.5 and 30.0 kg/m² as measured within 30 days prior to start of study 6. Fasting Blood Glucose between 3.9 mmol/L and 5.6 mmol/L as measured within 30 days prior to start of study 7. HbA1c below 40 mmol/mol (5.7%) as measured within 30 days prior to start of study 8. No prior history of CVD
Exclusion criteria
Exclusion criteria: 1. Age 35 years 2. Body Mass Index 35 kg/m² 3. Type 2 diabetes 4. Type 1 diabetes 5. Resistant hypertension (systolic = 150 and/or diastolic = 90 mmHg) on at least 4 anti-hypertensive medications 6. Hypotension (systolic <100 and/or diastolic < 60 mmHg) 7. Recent operation <6 months 8. Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months) 9. Birth control pills intake (Contraceptive drugs) 10. Intake of any SAID or NSAID during 4 weeks before or during the study conduction, which may affect the inflammation markers 11. Intake of dietary supplements or homoeopathic remedies (e.g. vitamins, minerals, fish-oils) during 2 weeks before and during the study 12. Females pregnant or lactating or planning a pregnancy during study 13. Any known addiction to drugs and/or alcohol 14. Recent alcohol consumption of more than 21 units/week for more than 3 months 15. Intake of illegal drugs during 4 weeks before and during study conduction (e.g. cannabis, cocaine) 16. Any known allergies 17. On a strict diet or practicing sport extensively 18. Employees of sponsor or institutions conducting the study 19. Current participation in another clinical study 20. Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Release of Vascular Cell Adhesion Molecule-1 (VCAM-1) from endothelial cells stimulated with LPS measured at 1h, 2h, and 4h post consumption of the treatments (versus 0h) on days 1 and 7 of the treatment periods using MSD V-PLEX Human assay kits (Meso Scale Discovery, Gaithersburg, MD, USA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Release of further inflammation markers from LPS stimulated endothelial cells treated with plasma from subjects consuming the experimental treatment versus the placebo at one or more time-points post product administration (1h, 2h, and 4h) on days 1 and/or 7 of the treatment periods; including: TNFa, IL-1ß, IL-6, IL-8, ICAM-1, CRP, and SAA measured using MSD V-PLEX Human assay kits (Meso Scale Discovery, Gaithersburg, MD, USA) 2. Blood plasma levels of CRP, IL-6, and TNFa at time 0h on days 7 versus day 1 of the treatment periods measured using MSD V-PLEX Human assay kits (Meso Scale Discovery, Gaithersburg, MD, USA) 3. Total antioxidant capacity of blood plasma at one or more time-points post product administration (1h, 2h, and 4h) on days 1 and/or 7 of the treatment periods measured by the DPPH Radical Scavenging method 4. Inhibition of COX-1 and COX-2 by plasma from subjects at one or more time-points post product administration (1h, 2h, and 4h) on days 1 and/or 7 of the treatment periods measured using a Cox human inhibitor screening assay kit (Cayman chemicals; #701230) 5. Post-prandial blood glucose levels at one or more time-points post product administration (1h, 2h, 4h, and 24h) on days 1 and/or 7 of the treatment periods (fasted subjects to be given a standardized meal directly after the active treatment/placebo on test days) measured using a Glucose oxidase-phenol amino phenazone (GOD-PAP) method (#GL2623, Randox) 6. Mood assessed using the Bond-Lader Visual Analogue Scale (VAS) at timepoints 0h, 1h, 2h, and 4h on days 1 and 7 of each treatment period. 7. Sleep quality assessed by the Leeds Sleep Evaluation questionnaire on day 7 of each treatment period. The below safety objectives will also be considered: 1. Serum ALT and AST levels at 0h and 4h time-point samples from days 1 and 7 of each treatment period for any evidence of acute or chronic liver toxicity from the treatment doses measured by spectrophotometric analysis using diagnostic kits (AL120 | — |
Countries
Tunisia
Outcome results
None listed