跳至主要内容
临床试验/NCT06020950
NCT06020950已完成不适用

Effects of Chia Seed Consumption in Comparison With Marine Omega-3 Supplementation on the Concentration of Blood Lipid and Inflammatory Factors in Hypertriglyceridemic Patients

Shahid Beheshti University2 个研究点 分布在 2 个国家目标入组 66 人开始时间: 2023年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Plasma concentration of triglycerides

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Individuals who had fasting triglyceride concentration 150-499 mg/dL in their two previous tests

排除标准

  • 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.

研究组 & 干预措施

Control

Placebo Comparator

Reduced calorie diet along with placebo (sunflower oil) pearls

干预措施: Control (Other)

Chia seed

Experimental

Reduced calorie diet along with chia seed consumption

干预措施: Chia seed (Other)

结局指标

主要结局

Plasma concentration of triglycerides

时间窗: 8 week

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

次要结局

  • Plasma inflammatory factors concentration(8 week)
  • Plasma concentration of insulin(8 weeks)
  • Weight loss(8 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javad Nasrollahzadeh

Associate Professor

Shahid Beheshti University of Medical Sciences

研究点 (2)

Loading locations...

相似试验