Recruiting

Chia Seeds

Sponsor:

Aimmune Therapeutics, Inc.

Code:

NCT07218640

Conditions

Stool Spore Colony Forming Units

Microbiome Composition

Dietary Fiber

Stress

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Chia seeds

Study Details

Brief summary:

This study will include healthy households around the Irvine, CA area (based local to employees) and Tempe, AZ and Philadelphia, PA sites that will be instructed to take a daily fiber supplement (2.5 tablespoons of chia seeds \[\~10.3g of fiber\] which is one serving) for two months. Participants will use a stool sampling tool to facilitate ease of stool collection, or they may donate at a study site. Half of participants will add chia seeds to their diet at the beginning of the study and then return to their baseline diet for the second half of the study; half of participants maintain their baseline diet for the first half of the study and add chia seeds to their diet at the second half of the study as a cross-over design. Households (or individual participants, if their household is not participating) will be chosen at random to decide who implements the intervention in the first half versus the second half of the study. Data measurement including metabolomics and sequencing of stool samples, blood sampling for biobanking, stool IgA analysis, stress and diet evaluations will occur initially and throughout the study. Lifestyle questionnaires including but not limited to diet surveys, stress, or depression screening may be collected through electronic forms or telephonically. During enrollment, participants may be asked to complete questionnaires focused on medical, family, dietary, and social histories.

At the end of the study, donor microbiota samples from individuals that are IgA low (undetectable) throughout the study will be evaluated from the presence of microbes that can degrade IgA. If investigators find this is the case, investigators will screen for microbes that can degrade IgA. For individuals that show persistent high fecal IgA or show a substantial improvement in IgA, investigators will transplant fecal samples or spores from fecal samples into germ-free mice to further understand the microbiome and pathophysiology relationship. For the latter, the investigator's hypothesis is that fiber exposure of a specific type will reprogram the microbiome to stimulate IgA broadly to the entire microbiome as occurs with pectin derivative treated mice. The investigator's goal will be to isolate the microbes that respond to fiber to alter levels of IgA in the gut lumen.

Conditions

Stool Spore Colony Forming Units

Microbiome Composition

Dietary Fiber

Stress

Study ID

NCT07218640

Start date

Oct, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18 years of age or greater
2. Able to sign informed consent in English
3. Households (2 or more adults) or individuals who are willing to provide a minimum of 3 separate stool samples per week and utilize a manual stool sampling tool. Alternatively, participants who can come to a collection site and leave stool samples a minimum of 3 days per week throughout the duration of the study.
4. Are generally healthy
5. Agreeable to adding chia seeds to diet
6. Have access to a smartphone

Exclusion Criteria:

1. Less than 18 years of age
2. Greater than 50 years of age
3. Unable to provide a minimum of 3 stool samples per week
4. Active donors for a commercial product
5. Anyone who previously made a lot of a finished product
6. Diagnosed with a digestive, intestinal, or other condition that contraindicates consuming a daily serving size of chia seeds (\~2.5 tbsp).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Baseline Diet

Participants will consume their baseline diet for 8 weeks

experimental: Chia seeds daily

Participants will consume 2.5 tbsp chia seeds daily for 8 weeks

Interventions

Chia seeds

Participant will add 2.5 tbsp daily chia seeds to their diet for 8 weeks

Primary outcome measure

  • Stool SCFU (Spore Colony-Forming Units) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Aimmune Therapeutics Manufacturing

Recruiting

Ambler, Pennsylvania, United States, 19002

Contacts

Principal Investigator:

Jason Goldsmith, MD, PhD

GoodNature Tempe

Recruiting

Ambler, Pennsylvania, United States, 19002

Contacts

Principal Investigator:

Jason Goldsmith, Md, PhD

More Information

Sponsor

Aimmune Therapeutics, Inc.

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • Spore Colony-Forming Units
  • Dietary fiber
  • Stress
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Aimmune Therapeutics, Inc. on 2025-10-20.