Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Dietary supplement: Mito-Food Plan; Other: Cellular Repair Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mito-Food Plan and Cellular Repair; Mito-Food Plan with adjunctive Cellular Repair Therapy	Dietary supplement: Mito-Food Plan; Specialized anti-inflammatory diet plan based on subject's physiological results; Other: Cellular Repair Therapy; the objective of this type of technology is to support the body's own processes to repair protein structures and maintain the health of the DNA, both of which have been damaged by internal and external factors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammation as measured through bioimpedance analysis from baseline to week 12	Mito-Food plan with cellular repair therapy will decrease inflammation in MCI and AD patients	3 months
Change in Mini Mental State Exam (MMSE) from Baseline to Week 12	Measuring cognition over the course of treatment as measured by the MMSE	3 months
Change in Montreal Cognitive Assessment (MoCA) from Baseline to Week 12	Measuring cognition over the course of treatment as measured by the MoCA	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life in Alzheimer's Disease (QOL-AD) from Baseline to Week 12	Determining if scores on Quality of Life in AD improves over course of therapy	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1C levels from Baseline to Week 12	Determining if A1c changes over the course of treatment as measured by blood work	3 months

Collaborators and Investigators

• Sponsor: Perseverance Research Center, LLC
• Collaborators: Cerulean Advanced Fitness and Wellness
• Investigators: Study Director: Nicole Hank, PHD, MCR, MHSM, Perseverance Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Actual): July 28, 2018
• Study Completion (Actual): July 28, 2018

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Inflammation; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: Mito-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No