Precision Microbiome Nutrition to Improve Brain Health

What is this Study about?

There are over 1000 types of bacteria that live in our gut and help us to process foods and help in nutrient and vitamin uptake. Recently, it was discovered that there are disturbances in the gut bacteria of people who have Alzheimer’s disease and that the gut and brain communicate. We propose that the gut-brain communication can be altered by changes in the gut bacteria in those living with Alzheimer’s disease.

The study purpose it to assess whether nutritional intervention with personalized, preselected prebiotics can affect cognitive function in those with Alzheimer’s disease.

What Will Happen in This Study?

Participants will be asked to take prebiotic for 3 months, participate in cognitive testing and questionnaires and provide two stool samples.

Who is Eligible to Participate in this Study?

Inclusion Criteria

  • 60 years or older
  • Have a diagnosis of Mild Cognitive Impairment, mild-to-moderate Alzheimer’s disease, or Amnestic mild cognitive impairment
  • Be able to speak, read and understand English
  • Have a study partner who is willing to provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hour per week), and will accompany the participant to study visits or be available by telephone at designated times. A second study partner may serve as backup, however, it is strongly suggested to maintain the same study partner throughout the study. The study partner(s) is/are required to accompany the patient for signing consent. The study partner must be present on all three days the participant is required onsite to support in completing the Diet History Questionnaire and information pertaining to adverse events. If a study partner must withdraw from study participation, a replacement may be allowed at the investigator’s discretion. The replacement will need to sign a separate informed consent on the first visit that he or she accompanies the participant.

Exclusion Criteria:

  • A diagnosis of early onset Alzheimer’s disease.
  • Cancer or undergoing cancer treatment.
  • Experienced an acute or active inflammatory condition within the last month, such as vasculitis, arthritis, allergies, gout, myositis, psoriasis, or an injury or illness that caused short term inflammation.
  • Taken antibiotics, prebiotics, or probiotics in the past month.*
  • Has episodes of gastroenteritis within the last month, such as the stomach flu, mild diarrhea, nausea with vomiting, bloody diarrhea).*
  • Taken anti-diarrheal drugs in the last month.*
  • Taken laxatives in the last month.*
  • Used ibuprofen daily for the last 14 days.
  • A history of GI surgery.
  • Have used traditional Chinese medicines in the last month,*
  • Taken metformin in the last month.*
  • Taken oral steroids in the last 4 weeks.*
  • A comorbidity known to affect the microbiome, including: diabetes, cardiovascular disease, inflammatory bowel disease, irritable bowel syndrome, celiac disease, cancer or receiving treatment, Crohn’s disease, or ulcerative colitis

*If participant is no longer taking such treatment or experiencing such issues for a period of four weeks, they can then be re-screened for the study. No individual will be told to stop taking treatments that are necessary. This would be the case where such treatments or medical conditions occur temporarily.

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