Clinical trial NCT06020950: Chia Seeds Consumption in Hypertriglyceridemia
Official title: Effects of Chia Seed Consumption in Comparison With Marine Omega-3 Supplementation on the Concentration of Blood Lipid and Inflammatory Factors in Hypertriglyceridemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: National Nutrition and Food Technology Institute
First posted: 2023-09-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma concentration of triglycerides
timeFrame: 8 week
Secondary outcomes:
measure: Weight loss
timeFrame: 8 week
measure: Plasma concentration of insulin
timeFrame: 8 weeks
measure: Plasma inflammatory factors concentration
timeFrame: 8 week
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Study officials:
References: