Atherosclerosis Clinical Trial
Official title:
Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.As omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a 3-month supplementation protocol was devised.Arterial stiffness and intima thickness will be measured in severely obese subjects, in order to document possible reduction of these variables as well.
Population:Morbidly obese non-smoking patients of the Department of Gastroenterology,
candidates for possible bariatric treatment Criteria for inclusion: Males and females, 18-
65 years old, body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities),
non-hospitalized and receiving general oral diet, with elevated C-reactive protein/ CRP (>
5mg/L), and signing informed consent; Criteria for exclusion: SIRS, shock, coma or organ
failure, fever or infectious foci, cancer with or without chemo/radiotherapy, inflammatory
illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases,
trauma, surgery or hospitalization in the last 30 days, use of steroidal or non-steroidal
anti-inflammatory or immune-modulating agents or antibiotics, and refusal to participate in
the study; Dietetic routine: Daily flaxseed powder (Farinha de linhaca dourada) 60 g/day
(232 kcal , containing 10 g of alpha-linolenic acid/ALA) or placebo (commercial manioc flour
60 g/day, 120 kcal)) during 12 weeks. An additional 60 subjects (30 patients, 30 controls)
will ve managed with 30 ml/day flaxseed oil (10 g of alpha-linolenic acid/ALA) or 30 ml/day
placebo (safflower oil).
Methods: Clinical questionnaire,nutritional assessment(Weight, height, BMI) Biochemical
tests: Hemoglobin (HB) , white blood cell count (WBC), total cholesterol (CHOL) and
fractions (HDL, LDL, VLDL), triglycerides (TRIG), blood glucose (GLU), serum albumin
(ALB),insulin (INS), leptin (LEP),C-reactive protein (CRP), serum amyloid A (SAA),
complement fractions C3 and C4, coagulation profile Atherosclerosis markers: Arterial
stiffness (aorta) and intima thickness (common carotid artery)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05052918 -
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
|
N/A | |
| Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
| Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
| Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
| Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
| Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
| Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
| Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
| Recruiting |
NCT06230406 -
T-Mem GEne in Atherosclerosis
|
||
| Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
| Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
| Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
| Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
| Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
| Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|
||
| Completed |
NCT02224339 -
New Technologies to Determine Carotid Plaque Vulnerability
|
||
| Completed |
NCT02268513 -
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
|
||
| Completed |
NCT03393377 -
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
|
N/A | |
| Completed |
NCT02377310 -
Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography
|
N/A | |
| Not yet recruiting |
NCT01923012 -
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
|
Phase 2 |