Chia Seeds Consumption in Hypertriglyceridemia

Sponsor
Shahid Beheshti University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06020950
Collaborator
National Nutrition and Food Technology Institute (Other)
70
1
3
5.8
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Control
  • Dietary Supplement: Omega-3 supplementation
  • Other: Chia seed
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
70 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
Anticipated Study Start Date :
Sep 18, 2023
Anticipated Primary Completion Date :
Dec 28, 2023
Anticipated Study Completion Date :
Mar 14, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Plasma concentration of triglycerides [8 week]

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

Secondary Outcome Measures

  1. Weight loss [8 week]

    Body wight loss (kg)

  2. Plasma concentration of insulin [8 weeks]

    Fasting plasma concentration of insulin

  3. Plasma inflammatory factors concentration [8 week]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Javad Nasrollahzadeh, Associate Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT06020950
Other Study ID Numbers:
  • 43005340
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023