Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538324
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Response to an Intervention With Omega-3 RIO - Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Response to an Intervention With Omega-3 Fatty Acids on Lipid and Inflammatory Profile in Overweight and Hypertriglyceridemic Individuals in Valdivia Chile RIO - Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIO
Brief Summary:
The RIO-Study project is a randomized controlled double-blind crossover trial aimed at determining the effectiveness of omega-3 fatty acids at nutritional doses on lipid metabolism and inflammation in overweight and hypertriglyceridemic individuals in Chile
Detailed Description:
The study will include 60 participants each participant will serve as their own control aged 18-65 with 25-299 kgm2 BMI and fasting triglycerides TG of 100-199 mgdL The intervention consists of 250 mg EPA from algae oil versus high oleic sunflower oil HOSO for 6 weeks each after a 10-week washout period the treatments will be switched for another 6 weeks considering four visits during the whole study The main outcomes to be evaluated are serum triglyceride levels expression of target genes in peripheral blood mononuclear cells PBMCs low-grade inflammation biomarkers and very low-density lipoprotein VLDL atherogenic properties The study also analyzes background diet chrononutrition and physical activity aspects Results are expected to provide new insights into the effects of nutritional doses of omega-3 in the Chilean population particularly on fasting and postprandial triglyceride metabolism and cardiovascular disease risk reduction
Before and after each intervention period fasting blood samples will be collected On each visit day participants will consume a standardized breakfast three slices of white bread with butter and jam and postprandial blood samples will be taken at 0 2 4 and 6 hours to measure triglycerides and other lipid parameters
The study will assess
1 Serum triglyceride levels in fasting and postprandial states
2 Expression of target genes Peroxisome proliferator-activated receptor alpha PPARα and Sterol regulatory element binding protein-1 SREBP1c in peripheral blood mononuclear cells PBMCs at fasting 0h and postprandial 4h states
3 Levels of low-grade inflammation biomarkers Tumor Necrosis Factor-Alpha TNFα and Interleukin 6 IL-6 at fasting 0h and postprandial 4h states
4 Very low-density lipoprotein VLDL atherogenic properties in the fasting state Additionally the investigators will collect data on chrononutrition physical activity and energy drink intake to understand their impact on lipid metabolism Anthropometric measurements and bioimpedance analysis will be performed at each visit
The study will collaborate with international partners for specialized analyses including gene expression studies and VLDL atherogenic properties assessment
This comprehensive approach aims to provide new insights into the effects of nutritional doses of omega-3 fatty acids on lipid metabolism and inflammation in the Chilean population with a particular focus on postprandial triglyceride metabolism and cardiovascular disease risk reduction
Before and after each intervention period fasting blood samples will be collected On each visit day participants will consume a standardized breakfast three slices of white bread with butter and jam and postprandial blood samples will be taken at 0 2 4 and 6 hours to measure triglycerides and other lipid parameters
The study will assess
1 Serum triglyceride levels in fasting and postprandial states
2 Expression of target genes Peroxisome proliferator-activated receptor alpha PPARα and Sterol regulatory element binding protein-1 SREBP1c in peripheral blood mononuclear cells PBMCs at fasting 0h and postprandial 4h states
3 Levels of low-grade inflammation biomarkers Tumor Necrosis Factor-Alpha TNFα and Interleukin 6 IL-6 at fasting 0h and postprandial 4h states
4 Very low-density lipoprotein VLDL atherogenic properties in the fasting state Additionally the investigators will collect data on chrononutrition physical activity and energy drink intake to understand their impact on lipid metabolism Anthropometric measurements and bioimpedance analysis will be performed at each visit
The study will collaborate with international partners for specialized analyses including gene expression studies and VLDL atherogenic properties assessment
This comprehensive approach aims to provide new insights into the effects of nutritional doses of omega-3 fatty acids on lipid metabolism and inflammation in the Chilean population with a particular focus on postprandial triglyceride metabolism and cardiovascular disease risk reduction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None