Lipid Metabolism Disorders Clinical Trial
Official title:
Effects of Stearidonic Acid on Serum Triacylglycerol Concentrations in Overweight and Obese Subjects
Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the
risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or
C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this
conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus,
providing oils rich in SDA may increase the endogenous synthesis of EPA. This may
subsequently lower serum triacylglycerol concentrations, an effect frequently observed after
EPA supplementation, especially in people with increased triacylglycerol levels.
The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol
concentrations in healthy overweight and slightly obese men and women. The minor objective
is to study the effects of echium oil on the omega-3 index, which is negatively related to
cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.
Using a randomized, double-blind, placebo controlled crossover design, subjects will receive
in random order for six weeks with a washout period of at least 14 days, daily 10 g of
echium oil or a high-oleic acid sunflower oil (HOSO) as control.
Thirty-six healthy men and women, aged 18-70 yrs, with a body mass index between 25 and 35
kg/m2 will participate. Subjects with an increased BMI are at increased risk to develop
hypertriglyceridemia.
During the experimental period, subjects will receive daily one sachet at lunch and one
sachet at dinner each providing 5 g of echium oil. During the control period, subjects will
receive daily at the same time points sachets with the same amount of HOSO.
The main study parameter is the change in fasting serum triacylglycerol concentrations. The
secondary endpoint is the change in the omega-3 index.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04896619 -
Cholesterol Effects of Kori-tofu Proteins
|
N/A | |
Completed |
NCT01737164 -
Effect of Age on Glucose and Lipid Metabolism
|
N/A | |
Completed |
NCT05629403 -
Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
|
||
Withdrawn |
NCT03047538 -
Fixed Combination for Lipid and Blood Pressure Control
|
Phase 4 | |
Withdrawn |
NCT02270164 -
The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
|
N/A | |
Completed |
NCT01968720 -
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT01435382 -
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
|
Phase 1 | |
Completed |
NCT00707746 -
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
|
Phase 2 | |
Active, not recruiting |
NCT01803776 -
The Physical Activity and Nutrition in Children (PANIC) Study
|
N/A | |
Active, not recruiting |
NCT05618756 -
CBD, Nutrient Metabolism and Energy Intake
|
N/A | |
Completed |
NCT05558488 -
The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response
|
N/A | |
Recruiting |
NCT04948008 -
Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia
|
Phase 2/Phase 3 | |
Completed |
NCT03898505 -
Clinical Investigation on the Safety of Avocado Pulp Lipids
|
Early Phase 1 | |
Completed |
NCT01311375 -
Omega 3 in Intervention Spinal Cord Injured People
|
Phase 2/Phase 3 | |
Terminated |
NCT01963650 -
Natural History Study of Children With Metachromatic Leukodystrophy
|
||
Active, not recruiting |
NCT06448052 -
Umbilical Cord Mesenchymal Stem Cell for Aging-related Low-grade Inflammation
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06060886 -
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
|
Phase 4 | |
Completed |
NCT03976479 -
Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Plant-Based Diet
|
||
Completed |
NCT02243969 -
Alpha-linolenic Acid and Blood Pressure
|
N/A | |
Completed |
NCT01874132 -
Study of the Long-term Effects of Exercise on Heath Indicators in Older People
|
N/A |