An interventional study of Control and Omega-3 supplementation in Hypertriglyceridemia, sponsored by Shahid Beheshti University. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Prevention
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.
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.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 66 is close to the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reduced calorie diet along with placebo (sunflower oil) pearls
Other: Control
Reduced calorie diet along with omega-3 supplementation
Dietary Supplement: Omega-3 supplementation
Reduced calorie diet along with chia seed consumption
Other: Chia seed
Low-calorie diet with the use of placebo pearls (containing sunflower oil)
Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)
Low-calorie diet with the consumption of 30 grams of powdered chia seeds
Plasma concentration of triglycerides
Fasting plasma concentration of C-reactive protein and IL-6
Time frame: 8 week
Weight loss
Body wight loss (kg)
Time frame: 8 week
Plasma concentration of insulin
Fasting plasma concentration of insulin
Time frame: 8 weeks
Plasma inflammatory factors concentration
Fasting plasma concentration of C-reactive protein and IL-6
Time frame: 8 week
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Mar 2024, 5 months.
Of 42 non-industry interventional studies with no phase under Hypertriglyceridemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 5 months is below that.
Counting every sponsor, half of 45 studies reached it within 23 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University