Chia Seeds for Gut Health

(FIBER-IMPACT Trial)

Recruiting at 1 trial location

Overseen By Allison Nelson, NP

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Aimmune Therapeutics, Inc.

Disqualifiers: Under 18, Over 50, Digestive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding chia seeds to the diet can improve gut health. The researchers aim to determine if daily chia seed consumption can alter gut bacteria and enhance immune components like IgA, which protects against infections. Participants will either begin with chia seeds or maintain their usual diet, switching halfway through. Individuals who are generally healthy, live with another adult, and are willing to provide frequent stool samples are ideal candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential health benefits of chia seeds.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adding chia seeds to your diet, so you may not need to change your medications, but it's best to check with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that chia seeds are generally safe to eat. Studies have found they are safe when used as directed. Known for their health benefits, chia seeds can reduce swelling and support heart health. They also provide a good source of fiber, aiding digestion and potentially lowering cholesterol.

Previous research has shown that most people can consume chia seeds without issues. They have been studied for their ability to protect the heart and improve overall health. However, like any new food, some people might experience mild stomach issues, especially if not accustomed to a high-fiber diet. Overall, chia seeds are considered safe to eat. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for gut health, which often involve probiotics or dietary supplements, chia seeds are a natural food source rich in fiber and omega-3 fatty acids. Researchers are excited about chia seeds because they offer a simple, whole-food approach that may improve gut health by enhancing digestion and promoting beneficial gut bacteria. This treatment stands out due to its potential to support gut health without the need for processed supplements, making it an appealing option for those seeking natural dietary changes.

What evidence suggests that chia seeds might be an effective treatment for gut health?

Research has shown that chia seeds are rich in fiber, which can improve gut health. One study found that even a small amount of chia seeds provides significant fiber, benefiting digestion. The gel-like substance in chia seeds might also promote the growth of healthy gut bacteria. In animal studies, consuming chia seeds has been linked to improved gut function. Although more research on humans is needed, these early findings suggest that chia seeds could benefit gut health. In this trial, participants in one arm will consume 2.5 tablespoons of chia seeds daily for 8 weeks to evaluate their impact on gut health, while those in the other arm will maintain their baseline diet. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason Goldsmith, MD, PhD

Principal Investigator

Nestle Health Science

Are You a Good Fit for This Trial?

This trial is for healthy individuals or households in Irvine, CA, Tempe, AZ, and Philadelphia, PA. Participants will add chia seeds to their diet as a fiber supplement for two months. They must be willing to provide stool samples and complete lifestyle questionnaires. The study excludes details on specific exclusion criteria.

Inclusion Criteria

Have access to a smartphone

Able to sign informed consent in English

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

Exclusion Criteria

Unable to provide a minimum of 3 stool samples per week

Active donors for a commercial product

Anyone who previously made a lot of a finished product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants complete health pre-screening survey and informed consent form, receive general information about the study, and are provided with chia seeds and sampling tools.

1 week

Intervention

Participants follow a crossover design with daily chia seed consumption for 8 weeks and baseline diet for 8 weeks, including daily stress surveys and meal photo submissions.

16 weeks

Weekly sample collection

Follow-up

Participants are monitored for microbiome changes and IgA levels, with potential fecal sample transplantation into germ-free mice for further analysis.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chia seeds

Trial Overview The study tests the effects of daily chia seed consumption (2.5 tablespoons) on gut flora and stress levels using a cross-over design where participants alternate between their normal diet and one including chia seeds. Stool samples are analyzed for IgA levels among other measurements.

How Is the Trial Designed?

Group I: Chia seeds daily Experimental Treatment 1 Intervention

Participants will consume 2.5 tbsp chia seeds daily for 8 weeks

Group II: Baseline Diet Active Control 1 Intervention

Participants will consume their baseline diet for 8 weeks

Who Is Running the Clinical Trial?

Aimmune Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

3,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834868/

Chia seeds (Salvia hispanica L.): A therapeutic weapon in ... Wet chia seeds are sticky in nature, due to mucilage and digestible fiber. These are useful in controlling blood sugar after eating, and provide satiety.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1756464618305048

Understanding the impact of chia seed mucilage on human ... In conclusion, the chia mucilage concentrations do not affect the physical properties of the intestine (viscosity) but could affect the colonic microbial growth ...

3. healthline.com healthline.com/nutrition/chia-seeds

Chia Seeds 101: Nutrition Facts and Health Benefits High fiber intake is linked to improved gut health and a lower risk of numerous diseases. A single ounce (28 grams) of chia seeds provides 9.75 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9696280/

Effect of Chia (Salvia hispanica L.) Associated with High-Fat ... Chia consumption improved intestinal morphology and functionality in young Wistar rats but was insufficient to promote significant changes in ...

5. nature.com nature.com/articles/s41598-024-83102-2

Dietary Chia (Salvia hispanica L.) seeds oil ... The results depicted significant improvements (p < 0.05) in weight gain (WG) %, specific growth rate (SGR), feed conversion ratio (FCR), and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1756464623000804

Health-promoting approaches of the use of chia seeds Chia seeds show cardioprotective, hypotensive, antidiabetic, antioxidant, anti-inflammatory, hypolipemic, neuroprotective, and hepatoprotective properties.

7. efsa.onlinelibrary.wiley.com efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5657

Safety of chia seeds (Salvia hispanica L.) as a novel food for ... The Panel concludes that chia seeds are safe under the assessed conditions of use. Summary. Following a request from the European Commission, ...

8. mayoclinichealthsystem.org mayoclinichealthsystem.org/hometown-health/speaking-of-health/chia-seeds-pack-nutritional-punch

Chia seeds pack nutritional punch Chia seeds are an excellent source of fiber, which can improve heart health, reduce cholesterol levels and promote intestinal health.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4926888/

Nutritional and therapeutic perspectives of Chia (Salvia ... The high fibre content of chia seed as health perspective, fibre increases stool volume, prevent from diverticulosis and cancer. Comparison of nutritional ...