Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients
Primary Purpose
Mild Cognitive Impairment, Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mito-Food Plan
Cellular Repair Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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
Sites / Locations
- Perseverance Research Center, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mito-Food Plan and Cellular Repair
Arm Description
Mito-Food Plan with adjunctive Cellular Repair Therapy
Outcomes
Primary Outcome Measures
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
Change in Mini Mental State Exam (MMSE) from Baseline to Week 12
Measuring cognition over the course of treatment as measured by the MMSE
Change in Montreal Cognitive Assessment (MoCA) from Baseline to Week 12
Measuring cognition over the course of treatment as measured by the MoCA
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03630419
First Posted
August 8, 2018
Last Updated
October 1, 2018
Sponsor
Perseverance Research Center, LLC
Collaborators
Cerulean Advanced Fitness and Wellness
1. Study Identification
Unique Protocol Identification Number
NCT03630419
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
July 28, 2018 (Actual)
Study Completion Date
July 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Perseverance Research Center, LLC
Collaborators
Cerulean Advanced Fitness and Wellness
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Mito Food Plan and Cellular Repair Therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mito-Food Plan and Cellular Repair
Arm Type
Experimental
Arm Description
Mito-Food Plan with adjunctive Cellular Repair Therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Mito-Food Plan
Intervention Description
Specialized anti-inflammatory diet plan based on subject's physiological results
Intervention Type
Other
Intervention Name(s)
Cellular Repair Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in inflammation as measured through bioimpedance analysis from baseline to week 12
Description
Mito-Food plan with cellular repair therapy will decrease inflammation in MCI and AD patients
Time Frame
3 months
Title
Change in Mini Mental State Exam (MMSE) from Baseline to Week 12
Description
Measuring cognition over the course of treatment as measured by the MMSE
Time Frame
3 months
Title
Change in Montreal Cognitive Assessment (MoCA) from Baseline to Week 12
Description
Measuring cognition over the course of treatment as measured by the MoCA
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life in Alzheimer's Disease (QOL-AD) from Baseline to Week 12
Description
Determining if scores on Quality of Life in AD improves over course of therapy
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in A1C levels from Baseline to Week 12
Description
Determining if A1c changes over the course of treatment as measured by blood work
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Hank, PHD, MCR, MHSM
Organizational Affiliation
Perseverance Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Perseverance Research Center, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients
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