NCT05734170

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2015

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

November 21, 2022

Last Update Submit

February 15, 2023

Conditions

Keywords

HDLCholesterolChiaOats

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Weight

    1 month

Study Arms (3)

Cheerio breakfast

OTHER

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

Instant Oatmeal Breakfast

OTHER

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

Chia Seeds and Instant Oatmeal breakfast.

EXPERIMENTAL

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

Interventions

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.

Chia Seeds and Instant Oatmeal breakfast.
Cheerio BreakfastDIETARY_SUPPLEMENT

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

Cheerio breakfast
Instant Oatmeal breakfastDIETARY_SUPPLEMENT

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

Instant Oatmeal Breakfast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • "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."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Habits

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Discipline Chair for Family Medicine

Study Record Dates

First Submitted

November 21, 2022

First Posted

February 17, 2023

Study Start

July 28, 2015

Primary Completion

August 27, 2015

Study Completion

August 27, 2015

Last Updated

February 17, 2023

Record last verified: 2023-02