Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanie… (NCT03630419) | Clinical Trial Compass
CompletedPhase 1/2
Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients
United States5 participantsStarted 2018-02-10
Plain-language summary
Diet plays a large role in inflammation, oxidative stress and cognition; however, every person's body type, resting metabolic rate, BMI, and inflammation levels vary. Through performing physiological and comprehensive cellular testing through bio-impedance, allows this study to create personalized diet plans for each subject's body type. Cellular repair therapy has also been known to improve cellular health and inflammation. Through decreasing inflammation and improving oxidative stress, cognition in those with MCI and AD could improve.
Who can participate
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 55-90 age inclusive
* Male or female
* Clinically definite or probable Alzheimer's Disease (AD) by The Alzheimer's Association and the National Institute on Aging (NIA)
* Must be diagnosed with clinical amnestic Mild Cognitive Impairment
* MMSE \> 17
* MOCA\>10
* Score a \> 4 or greater on the Constructional Praxis exam portion of the Alzheimer's Disease Assessment Scale-Cognitive testing (ADAS-Cog)
* Capable of providing informed consent and complying with trial procedures
* Must be able and willing to keep a diet diary
* Must avoid high-intensity activity 24 hours prior to day of body assessment
* Must avoid all physical exercise for at least three hours prior to day of body assessment
* Must be able to comply to dietary requirements
* Must be on stable dose of all medications and nutritional supplements for at least 3 months prior to screening.
Exclusion Criteria:
* Incapable of providing informed consent
* Incapable of eating solid foods
* Patients diagnosed with Lewy Bodies or Vascular Dementia
* Patients diagnosed with non-amnestic Mild Cognitive Impairment
* MMSE\<17
* MOCA\<10
* ADAS-COG constructual praxis score \<4
* Incapable of obtaining a diet/food diary
* Unstable to comply to study treatments/visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in inflammation as measured through bioimpedance analysis from baseline to week 12
Timeframe: 3 months
2
Change in Mini Mental State Exam (MMSE) from Baseline to Week 12
Timeframe: 3 months
3
Change in Montreal Cognitive Assessment (MoCA) from Baseline to Week 12