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

NCT ID: NCT03630419

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-10
• Study Completion Date: 2018-07-28

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mito-Food Plan and Cellular Repair

Mito-Food Plan with adjunctive Cellular Repair Therapy

Group Type: EXPERIMENTAL

Mito-Food Plan

Intervention Type: DIETARY_SUPPLEMENT

Specialized anti-inflammatory diet plan based on subject's physiological results

Cellular Repair Therapy

Intervention Type: OTHER

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.

Interventions

Mito-Food Plan

Specialized anti-inflammatory diet plan based on subject's physiological results

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cerulean Advanced Fitness and Wellness

UNKNOWN

Sponsor Role: collaborator

Perseverance Research Center, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Hank, PHD, MCR, MHSM

Role: STUDY_DIRECTOR

Perseverance Research Center

Locations

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

Mito-01

Identifier Type: -

Identifier Source: org_study_id