30 Day

Chia Seed Dietary Intervention

STUDY TITLE Chia Seed Dietary Intervention
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

-

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

Recruitment page preview

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Author edit

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Informed consent

Review

Study author

Tessa Boeve, Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

Participants will incorporate a specific amount of chia seeds into their daily meals over the course of the intervention. The goal is to assess the impact of chia seeds on digestion and bowel health by not soaking them before consumption. The intervention aims to monitor and analyze changes in digestion, bowel health, discomfort, and bloating.

Participant engagement length

30 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$0

Included products & services
Outcome measures

PROMIS Scale v1.1 – Gastrointestinal Gas and Bloating 13a

PROMIS® Scale v1.0 – Gastrointestinal Constipation 9a

PROMIS® Scale v1.0 – Gastrointestinal Belly Pain 5a Survey

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

No

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

Why I created this study:

Despite the rising popularity of chia seeds, there's limited scientific research on their direct impact on digestion and bowel health. Many claim chia seeds improve digestion and reduce bloating when incorporated into diets without soaking. Social media buzz and anecdotal reports speak to their potential but lack academic backing. This study will fill that gap by rigorously evaluating these claims, providing credible insights into the benefits and drawbacks of consuming unsoaked chia seeds on gastrointestinal health.

My Objective for You:

The goal is to empower you with evidence-based insights on the effects of chia seeds on your digestion. By participating, you'll contribute to understanding how chia seeds might alleviate discomfort, bloating, and other digestive issues. This knowledge will help you and others make informed dietary choices for better bowel health.

Aims & Objectives:

The study aims to evaluate the effects of unsoaked chia seeds on digestion and bowel health. We will measure changes in gastrointestinal discomfort, bloating, and bowel movement regularity over 18 days.

Significance & Impact:

This study could redefine how chia seeds are consumed for digestive health, potentially offering a simple dietary adjustment for improved well-being. The expected outcomes include enhanced digestive comfort and regularity, though individual responses may vary. The study's findings could guide dietary recommendations and influence consumer habits, though limitations include variability in individual digestive systems and adherence to protocol.

The Intervention

Included Products & Services

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire