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Completed

NCT Number: NCT06020950

Chia Seeds Consumption in Hypertriglyceridemia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tehran, 19395-4741, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Other

Low-calorie diet with the use of placebo pearls (containing sunflower oil)

Omega-3 supplementation

Dietary Supplement

Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)

Chia seed

Other

Low-calorie diet with the consumption of 30 grams of powdered chia seeds

Primary outcomes

  1. Plasma concentration of triglycerides

    Time frame: 8 week

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

Secondary outcomes

  1. Weight loss

    Time frame: 8 week

    Body wight loss (kg)

  2. Plasma concentration of insulin

    Time frame: 8 weeks

    Fasting plasma concentration of insulin

  3. Plasma inflammatory factors concentration

    Time frame: 8 week

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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Collaborators

  • National Nutrition and Food Technology Institute

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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