Mild Cognitive ImpairmentPhase 1/2NCT03630419
Specialized Food Plan Based on Individual Physiological Comprehensive Body Assessments Accompanied With Cellular Repair Therapy to Decrease Inflammation Cognitively Impaired Patients
A Phase 1/2 study testing Mito-Food Plan and Cellular Repair Therapy in people with Mild Cognitive Impairment and Alzheimer Disease, run by Perseverance Research Center, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Mito-Food Plan and Cellular Repair Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2018to 28 Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- ADAS-COG constructual praxis score <4
- Incapable of obtaining a diet/food diary
- Unstable to comply to study treatments/visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Perseverance Research Center, LLC
Scottsdale, Arizona, 85254
About this study
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
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.
Read the 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
- Being tested
- Mito-Food Plan, Cellular Repair Therapy
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mito-Food PlanDietary supplement
Specialized anti-inflammatory diet plan based on subject's physiological results
Cellular Repair TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mito-Food Plan and Cellular Repair | Experimental | Mito-Food Plan with adjunctive Cellular Repair Therapy Receives: Dietary Supplement: Mito-Food Plan; Other: Cellular Repair Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start10 Feb 2018
- Primary completion28 Jul 2018
- Study completion28 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mito Food Plan and Cellular Repair Therapy
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perseverance Research Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Cerulean Advanced Fitness and Wellness
- Responsible party
- Sponsor
- Investigators
- Nicole Hank, PHD, MCR, MHSM, Study director, Perseverance Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630419
- Sponsor's protocol ID
- Mito-01
- Status last verified
- Oct 2018
- First submitted
- 8 Aug 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03630419
- Acronym / sponsor ID
- Mito-01
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Perseverance Research Center, LLCUniversity, hospital or other
- Collaborators
- Cerulean Advanced Fitness and Wellness
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 28 Jul 2018 (actual)
- Study completion
- 28 Jul 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mito Food Plan and Cellular Repair Therapy
| Arm | Type | Receives |
|---|---|---|
| Mito-Food Plan and Cellular Repair | Experimental | Dietary Supplement: Mito-Food Plan, Other: Cellular Repair TherapyMito-Food Plan with adjunctive Cellular Repair Therapy |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mito-Food PlanSpecialized anti-inflammatory diet plan based on subject's physiological results | Dietary supplement | Mito-Food Plan and Cellular Repair |
| Cellular Repair Therapythe 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. | Other | Mito-Food Plan and Cellular Repair |
Primary outcome
Change in inflammation as measured through bioimpedance analysis from baseline to week 12
Time frame: 3 months
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
Time frame: 3 months
Measuring cognition over the course of treatment as measured by the MMSE
Change in Montreal Cognitive Assessment (MoCA) from Baseline to Week 12
Time frame: 3 months
Measuring cognition over the course of treatment as measured by the MoCA
1 secondary outcome
Change in Quality of Life in Alzheimer's Disease (QOL-AD) from Baseline to Week 12
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Hank, PHD, MCR, MHSM study director
Perseverance Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mito-Food Plan and Cellular Repair Therapy in people with Mild Cognitive Impairment and Alzheimer Disease, run by Perseverance Research Center, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammation as measured through bioimpedance analysis from baseline to week 12 (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.