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Diet Influence on Alzheimer's Biomarkers
N/A
Waitlist Available
Led By Angela J Hanson, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours post meal
Awards & highlights
Study Summary
This trial looks at how different types of meals affect thinking and biomarkers in older adults with and without the APOE E4 genotype.
Who is the study for?
This trial is for healthy older adults, aged 55 or above, who are free of dementia and can give informed consent. Participants must not have diabetes, severe liver or kidney disease, conditions preventing lumbar puncture, uncontrolled major illnesses, strict dietary restrictions due to allergies or medical conditions like celiac disease. They should limit alcohol intake and cannot be on certain lipid-altering medications.Check my eligibility
What is being tested?
The study tests the effects of two types of meals on Alzheimer's biomarkers in individuals with different APOE genotypes. One meal is high in saturated fat and glycemic index (HIGH), while the other is low (LOW). After fasting overnight, participants will consume a meal followed by cognitive tests and collection of spinal fluid and blood.See study design
What are the potential side effects?
There may not be direct side effects from eating the HIGH or LOW meals; however, discomfort from fasting overnight could occur. The invasive procedures like spinal taps might cause back pain, headache or bleeding where the needle was inserted.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 hours post meal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours post meal
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
APOE lipidation
Insulin
Lipid biomarkers
Trial Design
2Treatment groups
Experimental Treatment
Group I: LOW mealExperimental Treatment1 Intervention
The LOW meal is a 700 calorie breakfast style meal, with 25% of those calories coming from fat (5% saturated fat), 55% carbohydrate (with a glycemic index of <55), and 20% protein.
Group II: HIGH mealExperimental Treatment1 Intervention
The HIGH meal is a 700 calorie breakfast style meal, with 50% total fat (25% saturated fat), 30% carbohydrates with a glycemic index of >70, and 20% protein.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,273 Total Patients Enrolled
Angela J Hanson, MDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have diabetes and are currently taking medications or insulin for it, or have a fasting blood glucose level of 126 or higher.You cannot have a lumbar puncture if you have certain medical conditions such as a brain tumor, lower spine hardware, or are taking specific blood-thinning medications. It's okay if you take aspirin daily for prevention, and you can use NSAIDS as long as you don't take them every day and can stop taking them two days before the procedure.You are currently receiving chemotherapy or radiation treatment for cancer. It's okay if you had cancer in the past and it's been treated, as long as it's not affecting your current thinking or digestion.You are at least 55 years old, and if you are a woman, you have gone through menopause for at least one year or have had a hysterectomy at least a year ago.You have high cholesterol or high triglycerides and are taking specific medications to treat it. If you are taking certain alternative remedies or medications, you may still be able to participate if you agree to stop them for the study.If you currently have untreated severe depression, psychosis, or mania, you cannot participate. However, stable conditions like PTSD, depression, and anxiety that are being treated are okay.You have liver or kidney disease that is not well controlled, or your liver function tests show high levels of SGOT (AST) and/or SGPT (ALT) more than 1.5 times the normal limit.If you have been diagnosed with dementia, have had a recent stroke or severe head injury, or have advanced Parkinson's disease, you cannot participate. However, mild memory problems without affecting daily activities are okay.You cannot be taking certain hormones like estrogen, testosterone, or corticosteroids. If you are a woman, you need to be at least one year past menopause or one year after a hysterectomy to join the study. If you use hormone replacement therapy for menopause symptoms, you can still join if you stop the medication for four weeks before the study starts. Transgender individuals can join if they are not taking sex hormones.You have a history of certain digestive disorders or surgeries that could affect how your body absorbs food, but it's okay if you're being treated for acid reflux.
Research Study Groups:
This trial has the following groups:- Group 1: HIGH meal
- Group 2: LOW meal
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being taken in for this research project?
"That is accurate. The trial, which began recruitment on September 1st 2016, is still looking for patients according to the information available on clinicaltrials.gov. 80 people are needed for the study taking place at a single site."
Answered by AI
How many participants are being asked to join this clinical trial?
"That is correct. The clinical trial in question, which was posted on September 1st 2016 and last updated on November 10th 2020, is still recruiting patients. So far, 80 people have been enrolled at a single site."
Answered by AI
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