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NCT07218640 · ClinicalTrials.gov registry record · NA
Aimmune Longitudinal Collaboration Study
A NA study of Stress and Dietary Fiber, sponsored by Aimmune Therapeutics.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT07218640 is a NA study of Stress and Dietary Fiber that is actively recruiting participants, run by Aimmune Therapeutics. The registered enrollment target is 60 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT07218640, a NA study of Stress and Dietary Fiber, is actively recruiting participants, sponsored by Aimmune Therapeutics.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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 in
Conditions Studied
Interventions
- OTHER Chia seeds
Study Locations (2)
Pennsylvania
- Aimmune Therapeutics Manufacturing - Ambler
- GoodNature Tempe - Ambler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-10 |
| Est. Completion | 2026-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07218640
The ClinicalTrials.gov registry entry for NCT07218640 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 152 other Stress trials with a reported enrollment target (92% lower). The listed sponsor is Aimmune Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stress appearing as the primary indexed condition, and to 1 intervention - of which Chia seeds is the first listed.
NCT07218640 reports 2 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07218640 about?
NCT07218640 is a clinical study titled "Aimmune Longitudinal Collaboration Study". 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 wi...
What is the current status of trial NCT07218640?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-10. Estimated completion is 2026-07.
What conditions does trial NCT07218640 study?
This clinical trial studies the following conditions: Stress, Dietary Fiber, Microbiome Composition, Stool Spore Colony Forming Units.
What interventions are being tested in trial NCT07218640?
The interventions under investigation include: Chia seeds (OTHER).
Who is sponsoring clinical trial NCT07218640?
This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07218640 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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