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.

Study Overview

• Status: Completed
• Conditions: Diet; Habits
• Intervention / Treatment: Dietary supplement: Cheerio Breakfast; Dietary supplement: Instant Oatmeal breakfast; Dietary supplement: Chia Seeds and instant oatmeal breakfast

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Dietary supplement: Cheerio Breakfast; Patients were instructed to consume one serving of Cheerios according to package instructions each morning for 30 days.
Other: 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.	Dietary supplement: Instant Oatmeal breakfast; The second group was assigned to consume one packet of instant oatmeal for 30 days.
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Panel	Patients' blood was taken twice with intent to measure the cholesterol profile, including: total triglycerides, LDL cholesterol, and HDL cholesterol.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Patients' weight will be taken twice. Once before the diet and once upon completion of the diet.	1 month

Collaborators and Investigators

• Sponsor: Edward Via Virginia College of Osteopathic Medicine

Publications and helpful links

Helpful Links

• The promising future of chia, Salvia hispanica L
• Dietary levels of chia: influence on yolk cholesterol, lipid content and fatty acid composition for two strains of hens
• Dietary Salvia hispanica L. reduces cardiac oxidative stress of dyslipidemic insulin-resistant rats
• EFFECT OF CHIA SEED (SALVIA HISPANICA L.) CONSUMPTION ON CARDIOVASCULAR RISK FACTORS IN HUMANS: A SYSTEMATIC REVIEW
• Diet-induced oxalate nephropathy from excessive nut and seed consumption
• A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2015
• Primary Completion (Actual): August 27, 2015
• Study Completion (Actual): August 27, 2015

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cholesterol; HDL; Oats; Chia
• Other Study ID Numbers: 2015-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No