Chia Seeds Consumption in Hypertriglyceridemia

Study Overview
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Brief Summary
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Lifestyle changes including diet therapy and weight loss can improve hypertriglyceridemia (HTG) . Furthermore, increasing omega-3 fatty acids intake has therapeutic effects on HTG. Alpha-linolenic acid is the precursor of long-chain omega-3 fatty acid and it is abundant in sources such as chia seeds and flax seeds. Considering the high fiber and omega-3 content of chia seeds and the existing mechanisms for improving lipid profile through fiber and omega-3, animal studies have shown the positive role of chia seed consumption on lipid profile, glycemic and lipid factors, and inflammation. However, in human studies, conflicting results have been obtained and some studies have shown beneficial effects on blood lipid, glycemic, and inflammatory factors, but in some studies, no effect has been observed. The objective of this study is to determine the effects of chia seed consumption on lipids, glycemic and inflammatory factors in people with HTG.

Detailed Description
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This study is an unblinded randomized controlled clinical trial. The study will be conducted on people with mild to moderate hypertriglyceridemia whose fasting blood triglyceride levels were between 150-499 mg/dL in the previous two tests. Participants who meet the following criteria will not be included in the study: Being treated with fibrate medications, end-stage kidney disease, acquired immunodeficiency syndrome patients, cancer patients undergoing chemotherapy or radiotherapy, patients with liver cirrhosis, being treated glucocorticoids, continuous use of omega-3 supplements or in the past month, and pregnancy or lactation. Patients will be randomly assigned to one of three study groups. The duration of the study will be 8 week. The groups are: the control group, which is given a placebo pearls containing sunflower oil. the omega-3 oil group will be given omega-3 pearls, and the chia seed group that will consume chia seeds. In addition, the participants of all three groups are subjected to a low-calorie diet. At the beginning and end of the study, the measurements include body weight, blood pressure, blood concentration of lipids, lipoproteins and inflammatory factors.

Official Title
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Effects of Chia Seed Consumption in Comparison With Marine Omega-3 Supplementation on the Concentration of Blood Lipid and Inflammatory Factors in Hypertriglyceridemic Patients

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Other: Control
* Dietary Supplement: Omega-3 supplementation
* Other: Chia seed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Individuals who had fasting triglyceride concentration 150-499 mg/dL in their two previous tests Exclusion Criteria: Being treated with fibrate medications Being treated glucocorticoids Being treated with anticoagulants (except aspirin) Continuous use of omega-3 supplements or in the past month End-stage kidney disease Acquired immunodeficiency syndrome patients Cancer patients undergoing chemotherapy or radiotherapy Patients with liver cirrhosis Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Reduced calorie diet along with placebo (sunflower oil) pearls | Other: Control<br>* Low-calorie diet with the use of placebo pearls (containing sunflower oil)<br>|
| Active Comparator: Omega-3 supplementation<br>Reduced calorie diet along with omega-3 supplementation | Dietary Supplement: Omega-3 supplementation<br>* Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)<br>|
| Experimental: Chia seed<br>Reduced calorie diet along with chia seed consumption | Other: Chia seed<br>* Low-calorie diet with the consumption of 30 grams of powdered chia seeds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of triglycerides | Fasting plasma concentration of C-reactive protein and IL-6 | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Body wight loss (kg) | 8 week | 
| Plasma concentration of insulin | Fasting plasma concentration of insulin | 8 weeks | 
| Plasma inflammatory factors concentration | Fasting plasma concentration of C-reactive protein and IL-6 | 8 week |