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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05734170
Other study ID # 2015-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 28, 2015
Est. completion date August 27, 2015

Study information

Verified date February 2023
Source Edward Via Virginia College of Osteopathic Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date August 27, 2015
Est. primary completion date August 27, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Cheerio Breakfast
Patients were instructed to consume one serving of Cheerios according to package instructions each morning for 30 days.
Instant Oatmeal breakfast
The second group was assigned to consume one packet of instant oatmeal for 30 days.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Edward Via Virginia College of Osteopathic Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Weight Patients' weight will be taken twice. Once before the diet and once upon completion of the diet. 1 month
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