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

NCT03630419 | Completed Phase 1

• 1 other identifier: Mito-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Quality of Life in Alzheimer's Disease (QOL-AD) from Baseline to Week 12

  3 months

Other Outcomes (1)

• Change in A1C levels from Baseline to Week 12

  3 months

Study Arms (1)

Mito-Food Plan and Cellular Repair

EXPERIMENTAL

Mito-Food Plan with adjunctive Cellular Repair Therapy

Dietary Supplement: Mito-Food Plan; Other: Cellular Repair Therapy

Interventions

Mito-Food Plan DIETARY_SUPPLEMENT

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

Mito-Food Plan and Cellular Repair

Cellular Repair Therapy 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.

Mito-Food Plan and Cellular Repair

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Perseverance Research Center, LLC: lead
• Cerulean Advanced Fitness and Wellness: collaborator

Study Sites (1)

Perseverance Research Center, LLC

Scottsdale, Arizona, 85254, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Nicole Hank, PHD, MCR, MHSM

  Perseverance Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mito Food Plan and Cellular Repair Therapy

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: February 10, 2018
• Primary Completion: July 28, 2018
• Study Completion: July 28, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)