Aimmune Longitudinal Collaboration on Chia Seed Effects and the Gut Microbiome

Aimmune Therapeutics Manufacturing, LLC Longitudinal Collaboration Study: Evaluating the Impact of Lifestyle Factors on the Microbiome

This project will test if taking a daily serving of chia seeds changes stool spore counts, microbiome composition, and metabolic markers in generally healthy adults who can provide frequent stool samples.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Aimmune Therapeutics, Inc. (Industry-sponsored)
• Locations: 2 sites (Ambler, Pennsylvania and 1 other locations)
• Trial ID: NCT07218640 on ClinicalTrials.gov

What this trial studies

This randomized crossover study enrolls about 60 generally healthy adults or households at select sites and asks participants to add 2.5 tablespoons of chia seeds daily for an 8-week period, with a return-to-baseline period for the other 8 weeks. Half start the chia intervention in the first half and half in the second half, with household or individual random assignment. Participants provide multiple stool samples per week using a manual sampling tool or by delivering samples to a collection site, and samples undergo sequencing and metabolomics analysis. The design focuses on within-person comparisons to detect changes in spore colony-forming units, microbiome composition, and stool metabolites.

Who should consider this trial

Good fit: Ideal candidates are generally healthy adults aged 18–50 who can provide at least three stool samples per week, agree to add chia seeds to their diet, and have access to a smartphone, with households of two or more adults eligible to join together.

Not a fit: People under 18 or over 50, anyone with digestive conditions that make daily chia consumption unsafe, active commercial donors, or those unable to provide frequent stool samples are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could identify a simple, low-cost dietary change that favorably alters the gut microbiome and related metabolic markers.

How similar studies have performed: Previous dietary fiber studies have shown that added fiber can shift microbiome composition and metabolites, but using daily chia seeds in a household-based crossover design is relatively novel.

Eligibility criteria

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).

Where this trial is running

Ambler, Pennsylvania and 1 other locations

• Aimmune Therapeutics Manufacturing — Ambler, Pennsylvania, United States (Recruiting)
• GoodNature Tempe — Ambler, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Jason Goldsmith, MD, PhD — Nestle Health Science
• Study coordinator: Allison Nelson, NP

Conditions Stool Spore Colony Forming Units; Microbiome Composition; Dietary Fiber; Stress; Spore Colony-Forming Units; Dietary fiber; Microbiome