Clinical trial NCT05734170: The Effect of Chia Seeds on HDL Cholesterol
Official title: The Effect of Chia Seeds on HDL Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Habits
Keywords: HDL
Cholesterol
Chia
Oats
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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, Wilcoxon/Kruskal Wallis test and 1 way test.

Eligibility criteria: 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."

Primary outcomes:
measure: Lipid Panel
timeFrame: 1 month
Secondary outcomes:
measure: Weight
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
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