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Chia Seeds Consumption in Hypertriglyceridemia

Not Applicable
Completed
Conditions
Hypertriglyceridemia
Interventions
Dietary Supplement: Omega-3 supplementation
Other: Control
Other: Chia seed
Registration Number
NCT06020950
Lead Sponsor
Shahid Beheshti University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
Inclusion Criteria
    • Individuals who had fasting triglyceride concentration 150-499 mg/dL in their two previous tests
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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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Omega-3 supplementationOmega-3 supplementationReduced calorie diet along with omega-3 supplementation
ControlControlReduced calorie diet along with placebo (sunflower oil) pearls
Chia seedChia seedReduced calorie diet along with chia seed consumption
Primary Outcome Measures
NameTimeMethod
Plasma concentration of triglycerides8 week

Fasting plasma concentration of C-reactive protein and IL-6

Secondary Outcome Measures
NameTimeMethod
Plasma concentration of insulin8 weeks

Fasting plasma concentration of insulin

Plasma inflammatory factors concentration8 week

Fasting plasma concentration of C-reactive protein and IL-6

Weight loss8 week

Body wight loss (kg)

Trial Locations

Locations (1)

Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

🇮🇷

Tehran, Iran, Islamic Republic of

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