Chia Seeds Consumption in Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06020950
• Other study ID #: 43005340
• Status: Completed
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: March 16, 2024

Study information

• Verified date: March 2024
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 16, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Other:
• Control
Low-calorie diet with the use of placebo pearls (containing sunflower oil)

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)

Other:
• Chia seed
Low-calorie diet with the consumption of 30 grams of powdered chia seeds

Locations

Country	Name	City	State
Iran, Islamic Republic of	Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University	National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of triglycerides	Fasting plasma concentration of C-reactive protein and IL-6	8 week
Secondary	Weight loss	Body wight loss (kg)	8 week
Secondary	Plasma concentration of insulin	Fasting plasma concentration of insulin	8 weeks
Secondary	Plasma inflammatory factors concentration	Fasting plasma concentration of C-reactive protein and IL-6	8 week