NCT06020950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

August 27, 2023

Last Update Submit

March 16, 2024

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of triglycerides

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

    8 week

Secondary Outcomes (3)

  • Weight loss

    8 week

  • Plasma concentration of insulin

    8 weeks

  • Plasma inflammatory factors concentration

    8 week

Study Arms (3)

Control

PLACEBO COMPARATOR

Reduced calorie diet along with placebo (sunflower oil) pearls

Other: Control

Omega-3 supplementation

ACTIVE COMPARATOR

Reduced calorie diet along with omega-3 supplementation

Dietary Supplement: Omega-3 supplementation

Chia seed

EXPERIMENTAL

Reduced calorie diet along with chia seed consumption

Other: Chia seed

Interventions

ControlOTHER

Low-calorie diet with the use of placebo pearls (containing sunflower oil)

Control
Omega-3 supplementationDIETARY_SUPPLEMENT

Low-calorie diet with the use of marine omega-3 pearls (containing 1200 mg eicosapentaenoic acid + 600 mg docosahexaenoic acid/day)

Omega-3 supplementation
Chia seedOTHER

Low-calorie diet with the consumption of 30 grams of powdered chia seeds

Chia seed

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Tehran, 19395-4741, Iran

Location

Related Publications (1)

  • Shahparvari MR, Nasrollahzadeh J. Effect of chia seeds or concentrated fish oil on cardiometabolic risk markers in subjects with hypertriglyceridaemia: a parallel clinical trial. J Hum Nutr Diet. 2024 Dec;37(6):1558-1570. doi: 10.1111/jhn.13369. Epub 2024 Oct 3.

    PMID: 39360590DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Salvia hispanica seed extract

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2023

First Posted

September 1, 2023

Study Start

September 18, 2023

Primary Completion

March 2, 2024

Study Completion

March 16, 2024

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

IR(1)