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Chia Seeds Consumption in Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT06020950
Recruitment Status : Completed
First Posted : September 1, 2023
Last Update Posted : March 19, 2024
Sponsor:
Collaborator:
National Nutrition and Food Technology Institute
Information provided by (Responsible Party):
Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Other: Control Dietary Supplement: Omega-3 supplementation Other: Chia seed Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 18, 2023
Actual Primary Completion Date : March 2, 2024
Actual Study Completion Date : March 16, 2024

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma concentration of triglycerides [ Time Frame: 8 week ]
    Fasting plasma concentration of C-reactive protein and IL-6


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020950


Locations
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Iran, Islamic Republic of
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of, 19395-4741
Sponsors and Collaborators
Shahid Beheshti University
National Nutrition and Food Technology Institute
More Information
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Responsible Party: Javad Nasrollahzadeh, Associate Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT06020950    
Other Study ID Numbers: 43005340
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases