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
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Condition or disease | Intervention/treatment | Phase |
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Hypertriglyceridemia | Other: Control Dietary Supplement: Omega-3 supplementation Other: Chia seed | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
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Placebo Comparator: Control
Reduced calorie diet along with placebo (sunflower oil) pearls
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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
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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
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Other: Chia seed
Low-calorie diet with the consumption of 30 grams of powdered chia seeds |
- Plasma concentration of triglycerides [ Time Frame: 8 week ]Fasting plasma concentration of C-reactive protein and IL-6
- Weight loss [ Time Frame: 8 week ]Body wight loss (kg)
- Plasma concentration of insulin [ Time Frame: 8 weeks ]Fasting plasma concentration of insulin
- Plasma inflammatory factors concentration [ Time Frame: 8 week ]Fasting plasma concentration of C-reactive protein and IL-6
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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 |
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.
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
Iran, Islamic Republic of | |
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute | |
Tehran, Iran, Islamic Republic of, 19395-4741 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |