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Completed

NCT Number: NCT05734170

The Effect of Chia Seeds on HDL Cholesterol

The purpose of this clinical trial is to demonstrate the effect of daily consumption of chia seeds, if any, on HDL cholesterol levels and compare this to the effects of oats on HDL levels in adult populations.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Chia seeds are touted as a health food capable of a beneficial effect on HDL cholesterol. Similar claims have been made for oats in various forms, claiming they improve cholesterol or are in some way heart healthy.

The investigators wish to demonstrate the effect of daily consumption of chia seeds, if any, on HDL cholesterol levels and compare this to the effects of oats on HDL levels.

This pilot study was a randomized controlled trial at an academic primary care center. Participation was voluntary and all participants provided written consent prior to enrollment. There were no exclusionary criteria other than that participants must be adults willing to come in to get their cholesterol profiles checked at the beginning and end of the study. Participants consumed their assigned breakfast in a standard serving size for a month with blood draws and weights recorded before and after the diet. Patients' cholesterol profiles were also compared with their weights. To standardize the delivery of chia seeds, the group consuming chia seeds mixed the chia with oatmeal. The three groups thus consisted of Cheerios, oatmeal and oatmeal with chia seeds. Initially, there were a total of 11 subjects, three in the Cheerios group, four in the oatmeal group, and four in the oatmeal with chia seeds group. Two subjects were lost to follow-up, one each from the Cheerios and oatmeal groups, respectively. Statistical analysis including one way analysis was done with means, Wilcoxon/Kruskal Wallis test and 1 way test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to give voluntary consent
  • Must be greater than or equal to 18 years old
  • Must be willing to give blood twice
  • Must be able to eat assigned breakfast

Exclusion criteria

  • "Subjects between the ages of 18 and 50 years old without a history of food allergies to either chia seeds or oats, kidney stones or a history of hyperlipidemia or treatment for hyperlipidemia will be eligible."

Treatment and study plan

Chia Seeds and instant oatmeal breakfast

Dietary Supplement

The final group was to consume one packet of instant oatmeal with two tablespoons of chia seeds mixed in with oatmeal for breakfast for 30 days.

Cheerio Breakfast

Dietary Supplement

Patients were instructed to consume one serving of Cheerios according to package instructions each morning for 30 days.

Instant Oatmeal breakfast

Dietary Supplement

The second group was assigned to consume one packet of instant oatmeal for 30 days.

Primary outcomes

  1. Lipid Panel

    Time frame: 1 month

    Patients' blood was taken twice with intent to measure the cholesterol profile, including: total triglycerides, LDL cholesterol, and HDL cholesterol.

Secondary outcomes

  1. Weight

    Time frame: 1 month

    Patients' weight will be taken twice. Once before the diet and once upon completion of the diet.

Sponsors and collaborators

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2023
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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