Clinical trial NCT03630419: Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Lead sponsor: Perseverance Research Center, LLC
Sponsor class: OTHER
Collaborators: name: Cerulean Advanced Fitness and Wellness
First posted: 2018-08-14
Enrollment: 5
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mito Food Plan and Cellular Repair Therapy
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in inflammation as measured through bioimpedance analysis from baseline to week 12
timeFrame: 3 months
measure: Change in Mini Mental State Exam (MMSE) from Baseline to Week 12
timeFrame: 3 months
measure: Change in Montreal Cognitive Assessment (MoCA) from Baseline to Week 12
timeFrame: 3 months
Secondary outcomes:
measure: Change in Quality of Life in Alzheimer's Disease (QOL-AD) from Baseline to Week 12
timeFrame: 3 months
Other outcomes:
measure: Change in A1C levels from Baseline to Week 12
timeFrame: 3 months
Locations:
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
Study officials:
affiliation: Perseverance Research Center
name: Nicole Hank, PHD, MCR, MHSM
role: STUDY_DIRECTOR
References: