Chia Seeds Consumption in Hypertriglyceridemia

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Other: Control; Dietary supplement: Omega-3 supplementation; Other: Chia seed

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 19395-4741
    • Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Collaborators: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): March 2, 2024
• Study Completion (Actual): March 16, 2024

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: August 27, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: 43005340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No