The Effect of Chia Seeds on HDL Cholesterol

NCT ID: NCT05734170

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-28

Study Completion Date

2015-08-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This pilot study was a small, randomized controlled trial at an academic primary care center. Each patient provided voluntary written consent prior to participating in the project. At the beginning of the study, each participant was randomly assigned to the red, white or blue group. They were then assigned a number within that group. The red group was instructed to consume one serving of Cheerios according to package instructions each morning for 30 days, the white group one packet of instant oatmeal, and the blue group one packet of instant oatmeal with two tablespoons of chia seeds. Subjects will be questioned to ensure to contraindications to participation. All other dietary or exercise habits will be maintained to reduce risk of confounding variables.Cholesterol profiles and weight will be measured at the beginning and end of the study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cheerio breakfast

Patient consumes 1 serving of cheerios for breakfast every day for 1 month. Blood is drawn to assess lipid panels before diet and after 1 month of diet.

Group Type OTHER

Cheerio Breakfast

Intervention Type DIETARY_SUPPLEMENT

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

Instant Oatmeal Breakfast

Patient consumes 1 package instant oatmeal for breakfast each day for 1 month. Blood is drawn to assess lipid panels before diet and after 1 month of diet.

Group Type OTHER

Instant Oatmeal breakfast

Intervention Type DIETARY_SUPPLEMENT

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

Chia Seeds and Instant Oatmeal breakfast.

Patient consumes 1 package instant oatmeal with 2 tbsp chia seeds everyday for breakfast for 1 month. Blood is drawn to assess lipid panels before diet and after 1 month of diet.

Group Type EXPERIMENTAL

Chia Seeds and instant oatmeal breakfast

Intervention Type 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.

Interventions

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Chia Seeds and instant oatmeal breakfast

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.

Intervention Type DIETARY_SUPPLEMENT

Cheerio Breakfast

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

Intervention Type DIETARY_SUPPLEMENT

Instant Oatmeal breakfast

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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."
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edward Via Virginia College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Brian Dickens

Principal Investigator, Discipline Chair for Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Related Links

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http://pubmed.ncbi.nlm.nih.gov/23251075/

The promising future of chia, Salvia hispanica L

https://pubmed.ncbi.nlm.nih.gov/10824962/

Dietary levels of chia: influence on yolk cholesterol, lipid content and fatty acid composition for two strains of hens

https://pubmed.ncbi.nlm.nih.gov/26545644/

EFFECT OF CHIA SEED (SALVIA HISPANICA L.) CONSUMPTION ON CARDIOVASCULAR RISK FACTORS IN HUMANS: A SYSTEMATIC REVIEW

https://casereports.bmj.com/content/13/11/e237212

Diet-induced oxalate nephropathy from excessive nut and seed consumption

https://pubmed.ncbi.nlm.nih.gov/22090467/

A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome

Other Identifiers

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2015-011

Identifier Type: -

Identifier Source: org_study_id

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