Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05734170
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2022-11-21
Brief Title:
The Effect of Chia Seeds on HDL Cholesterol
Sponsor:
Edward Via Virginia College of Osteopathic Medicine
Organization:
Edward Via Virginia College of Osteopathic Medicine
Study Overview
Official Title:
The Effect of Chia Seeds on HDL Cholesterol
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 WilcoxonKruskal Wallis test and 1 way test
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 WilcoxonKruskal Wallis test and 1 way test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None