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Chia Seeds Consumption in Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Control
Omega-3 supplementation
Chia seed
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Nutrition Research Unit, National Nutrition and Food Technology Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Control

Omega-3 supplementation

Chia seed

Arm Description

Reduced calorie diet along with placebo (sunflower oil) pearls

Reduced calorie diet along with omega-3 supplementation

Reduced calorie diet along with chia seed consumption

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight loss
Body wight loss (kg)
Plasma concentration of insulin
Fasting plasma concentration of insulin
Plasma inflammatory factors concentration
Fasting plasma concentration of C-reactive protein and IL-6

Full Information

First Posted
August 27, 2023
Last Updated
October 14, 2023
Sponsor
Shahid Beheshti University
Collaborators
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06020950
Brief Title
Chia Seeds Consumption in Hypertriglyceridemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
March 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
Collaborators
National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Reduced calorie diet along with placebo (sunflower oil) pearls
Arm Title
Omega-3 supplementation
Arm Type
Active Comparator
Arm Description
Reduced calorie diet along with omega-3 supplementation
Arm Title
Chia seed
Arm Type
Experimental
Arm Description
Reduced calorie diet along with chia seed consumption
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Low-calorie diet with the use of placebo pearls (containing sunflower oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 supplementation
Intervention Description
Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)
Intervention Type
Other
Intervention Name(s)
Chia seed
Intervention Description
Low-calorie diet with the consumption of 30 grams of powdered chia seeds
Primary Outcome Measure Information:
Title
Plasma concentration of triglycerides
Description
Fasting plasma concentration of C-reactive protein and IL-6
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Weight loss
Description
Body wight loss (kg)
Time Frame
8 week
Title
Plasma concentration of insulin
Description
Fasting plasma concentration of insulin
Time Frame
8 weeks
Title
Plasma inflammatory factors concentration
Description
Fasting plasma concentration of C-reactive protein and IL-6
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad R Shahparvari
Phone
+989126024463
Email
shahparvarim@gmail.com
Facility Information:
Facility Name
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
City
Tehran
ZIP/Postal Code
19395-4741
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad R Shahparvari, B.S.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Chia Seeds Consumption in Hypertriglyceridemia

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