Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 55 - 90 |
| Updated: | 10/4/2018 |
| Start Date: | February 10, 2018 |
| End Date: | July 28, 2018 |
Determining if a Personalized Mito Food Plan Diet and Cellular Repair Therapy Based on Individual Physiological and Cellular Comprehensive Body Assessments in Patients With Alzheimer's Disease Decreases Inflammation and Oxidative Stress
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.
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.
Even though AD has been associated with specific hallmarks, multiple etiologies have been
suggested to be prominent in the pathogenesis of the disease. Chronic inflammation, metabolic
dysfunction, oxidative stress and mitochondrial damage have all been linked to the incidence
and progression of neurodegeneration, negatively impacting overall prognosis of AD.
Currently, only a handful of FDA approved Alzheimer's medications are on the market; yet,
these medications are known to only treat symptoms associated with AD, not the underlying
causes. There are currently no medications FDA approved for MCI and predicting who will
progress onto AD is unknown. Unfortunately, in the last decade alone, several clinical trials
in MCI and AD, have been terminated prior to study conclusion, due to lack of efficacy and/or
poor study design. Even if an experimental drug is shown to be promising in early stages of
testing, it could take up to another 10-15 years before it is FDA approved and made
commercially available. Therefore, the need to find a therapy that could possibly prevent
people with MCI from developing AD is imperative. Through studying different etiologies,
providing a specialized diet based on each subject's individual physiological results and
improving mitochondria through cell repair therapy, not only can be quickly implemented into
the life of a person with cognitive impairment, but could possibly decrease the prevalence
and slow disease progression of AD. Thus, the fundamental research of this study is to
determine if such etiologies are measurable in patients with MCI and AD through body
composition and cellular health testing that could lead to proper and novel treatments to
combat the diseases. This study was conducted in hopes of determining that chronic
inflammation and other risk factors for MCI and AD such as oxidative stress and metabolic
dysfunction, can be ameliorated, improve cognitive function, and therefore prevent disease
progression through effective, non-drug therapies.
suggested to be prominent in the pathogenesis of the disease. Chronic inflammation, metabolic
dysfunction, oxidative stress and mitochondrial damage have all been linked to the incidence
and progression of neurodegeneration, negatively impacting overall prognosis of AD.
Currently, only a handful of FDA approved Alzheimer's medications are on the market; yet,
these medications are known to only treat symptoms associated with AD, not the underlying
causes. There are currently no medications FDA approved for MCI and predicting who will
progress onto AD is unknown. Unfortunately, in the last decade alone, several clinical trials
in MCI and AD, have been terminated prior to study conclusion, due to lack of efficacy and/or
poor study design. Even if an experimental drug is shown to be promising in early stages of
testing, it could take up to another 10-15 years before it is FDA approved and made
commercially available. Therefore, the need to find a therapy that could possibly prevent
people with MCI from developing AD is imperative. Through studying different etiologies,
providing a specialized diet based on each subject's individual physiological results and
improving mitochondria through cell repair therapy, not only can be quickly implemented into
the life of a person with cognitive impairment, but could possibly decrease the prevalence
and slow disease progression of AD. Thus, the fundamental research of this study is to
determine if such etiologies are measurable in patients with MCI and AD through body
composition and cellular health testing that could lead to proper and novel treatments to
combat the diseases. This study was conducted in hopes of determining that chronic
inflammation and other risk factors for MCI and AD such as oxidative stress and metabolic
dysfunction, can be ameliorated, improve cognitive function, and therefore prevent disease
progression through effective, non-drug therapies.
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
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