Gut Inflammation Study
We are looking for volunteers to enroll in a clinical research study that will evaluate a natural health product, IgY Max™.
IgY Max™ is a whole egg powder from chicken eggs. Chickens naturally produce IgY in response to vaccinations and exposure to pathogens (a bacterium, virus, or other microorganisms that can cause disease). IgY is present in the eggs you eat. The total amount of IgY in eggs that you might consume is the same as the amount of IgY in IgY Max™. IgY Max™ differs only from the eggs you eat in that the chickens have received specific vaccinations against specific bacteria. 4.5 grams of IgY Max™ is equivalent to eating 1/3rd of an egg.
This is a randomized and double-blind study. Double-blind refers to that you nor the staff at Nutrasource will know which study group you have been placed in. However, for your safety, a staff member not involved at Nutrasource is fully aware what group you are and the information can be made available if there are any health concerns because of the study.
The purpose of this study is to see if IgY Max™ reduces a marker of inflammation in the blood (c-reactive protein) and also if IgY Max™ changes the number and type of bacteria that are naturally in your intestines.
The study has a total of six clinic visits which will take approximately 45 minutes to one hour.
- Visit 1 (Screening Visit): Approx. 60 - 90 minutes.
- Visit 2: Approx. 45 - 60 minutes.
- Visit 3: Approx. 45 - 60 minutes.
- Visit 4: Approx. 45 - 60 minutes.
- Visit 5: Approx. 45 - 60 minutes.
- Visit 6: Approx. 45 - 60 minutes.
If you choose to, and are eligible to participate, you will be in the study for approximately 14 weeks. You will be asked to come to the clinic fasting (nothing to eat or drink except water) for at least 6 hours for 5 out of the 6 visits. You will also be asked to provide five blood samples and three stool(fecal) samples. You will be asked to record the foods you eat for three days prior to the first stool collection and eat these same foods on three days prior to each stool collection. This helps to minimize any effects that food have on the bacteria present in the stool sample.
If you are eligible to participate in the study, and complete the study, you will be reimbursed a total of $265.00 for your time and travel to the clinic.
Find out if you are eligible for this study by completing the screening survey.
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