Chia Seeds Consumption in Hypertriglyceridemia

Shahid Beheshti University

Status: Completed

Conditions: Hypertriglyceridemia

Treatments: Dietary Supplement: Omega-3 supplementation; Other: Control; Other: Chia seed

Study type: Interventional

Funder types: Other

Identifiers

NCT06020950

43005340

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Reduced calorie diet along with placebo (sunflower oil) pearls

Treatment:

Other: Control

Omega-3 supplementation

Active Comparator group

Description:

Reduced calorie diet along with omega-3 supplementation

Treatment:

Dietary Supplement: Omega-3 supplementation

Chia seed

Experimental group

Description:

Reduced calorie diet along with chia seed consumption

Treatment:

Other: Chia seed