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Healthy Adults With Mild Cognitive Impairment (MCI) and a 16-week Intervention With Mitocholine™, a Functional Food Ingredient

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Mitocholine™ or Placebo
Sponsored by
Mitocholine Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Willing to participate in the study and comply with its procedures. Able to give written informed consent. Adults aged 55 to 79 years, inclusive. Meet MCI criteria, based on the Peterson criteria (Peterson et al., 1999): Presence of a subjective memory complaint as assessed by MAC-Q (score >25). Objective evidence of cognitive impairment as assessed by MoCA (score ≥18 to ≤24). Absence of major depression as assessed by PHQ (score <10). Activities of daily living score males ≥4 females ≥7 Have a homocysteine level ≥11.0μmol/L (Smith D et al, 2018). Exclusion Criteria: Diagnosis of a major cognitive disorder (e.g. Alzheimer's or Parkinson's disease diagnoses; additionally, confirmation of a mini stroke (TIA) within the last 3 months would be an exclusionary condition). Participants who are pregnant or wish to become pregnant during the trial. Participants who are lactating and/or currently breastfeeding. Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator. Participants with active or a history of alcohol or substance abuse; (exclude elevated Gamma GT & clinically abnormal liver function test). Uncontrolled diabetes (or glycated haemoglobin >7% / 53 mmol/mol). Clinically significant heart, liver, or renal disease (at the discretion of the investigator). Have uncontrolled hypertension SBP > 160mmHg, DBP > 100mmHg). Participants prescribed medications likely to influence memory or mood, as determined by the investigator. Participants with a history of depression (within past 24 months) or any concurrent medical, cognitive or psychiatric condition that would either: compromise his/her ability to comply with the study requirements, may pose significant risk to the participant, or be deemed exclusionary by the investigator Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results. Change in supplements, medication, or major diet in 30 days prior to enrolment and throughout the study. Taking any supplements or vitamins notably known to affect cognitive function (e.g. Living Nutrition Cognitive, Viridian Cognitive Complex, ginkgo biloba, fish oil etc., list not exhaustive), or any psychotropic medications and products which interact with acetylcholine esterase and/or NMDA receptors (6-week washout before screening). Vitamin D and Calcium supplements permitted if on a stable dose for the previous 3 months. Smokers (>5 cigs per week) or participants who use vape products. Has received treatment involving experimental drugs in the past 3 months. Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study. Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial. Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

Sites / Locations

  • Atlantia Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mitocholine™

Placebo

Arm Description

Mitocholine™ is a novel formulation of three nutrients choline, succinic acid, and nicotinamide (a vitamin B3)

The Placebo product will be identical in appearance and taste to the investigational product

Outcomes

Primary Outcome Measures

Absolute change in Executive Function Score in the Mitocholine group compared to the Placebo group.
Assessed by the verbal fluency, colour-word interference and trail making tests in the Delis-Kaplan Executive Function System
Absolute change in Homocysteine levels in the Mitocholine group compared to the Placebo group.
Assessed by serum Homocysteine levels (umol/L)

Secondary Outcome Measures

Change in Memory outcomes (visual memory) in the Mitocholine group compared to the Placebo group
Assessed by a Paired Associated Learning Task
Change in Memory outcomes (episodic memory) in the Mitocholine group compared to the Placebo group
Assessed by a Word Recall Task
Change in Language outcomes in the Mitocholine group compared to the Placebo group
Assessed by the Boston Naming Test
Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group
Assessed by S-adenosylmethionone (SAM) in blood
Change in Betaine levels in the Mitocholine group compared to the Placebo group
Assessed by Betine in blood
Change in Choline levels in the Mitocholine group compared to the Placebo group
Assessed by Choline in blood

Full Information

First Posted
January 6, 2023
Last Updated
March 13, 2023
Sponsor
Mitocholine Ltd
Collaborators
Atlantia Food Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT05690724
Brief Title
Healthy Adults With Mild Cognitive Impairment (MCI) and a 16-week Intervention With Mitocholine™, a Functional Food Ingredient
Official Title
A Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Otherwise Healthy Adults With Mild Cognitive Impairment (MCI) Assessing a 16-week Intervention With Mitocholine™, a Functional Food Ingredient
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
March 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitocholine Ltd
Collaborators
Atlantia Food Clinical Trials

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
To evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment. The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, double-blinded, placebo-controlled, parallel proof of concept study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mitocholine™
Arm Type
Experimental
Arm Description
Mitocholine™ is a novel formulation of three nutrients choline, succinic acid, and nicotinamide (a vitamin B3)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The Placebo product will be identical in appearance and taste to the investigational product
Intervention Type
Dietary Supplement
Intervention Name(s)
Mitocholine™ or Placebo
Intervention Description
Participants will be instructed to consume one bottle of study product daily for the duration of the trial (16 weeks). They will be instructed to consume the product in the morning with breakfast.
Primary Outcome Measure Information:
Title
Absolute change in Executive Function Score in the Mitocholine group compared to the Placebo group.
Description
Assessed by the verbal fluency, colour-word interference and trail making tests in the Delis-Kaplan Executive Function System
Time Frame
Baseline to end of intervention (week 16)
Title
Absolute change in Homocysteine levels in the Mitocholine group compared to the Placebo group.
Description
Assessed by serum Homocysteine levels (umol/L)
Time Frame
Baseline to end of intervention (week 16)
Secondary Outcome Measure Information:
Title
Change in Memory outcomes (visual memory) in the Mitocholine group compared to the Placebo group
Description
Assessed by a Paired Associated Learning Task
Time Frame
Baseline to end of intervention (week 16)
Title
Change in Memory outcomes (episodic memory) in the Mitocholine group compared to the Placebo group
Description
Assessed by a Word Recall Task
Time Frame
Baseline to end of intervention (week 16)
Title
Change in Language outcomes in the Mitocholine group compared to the Placebo group
Description
Assessed by the Boston Naming Test
Time Frame
Baseline to end of intervention (week 16)
Title
Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group
Description
Assessed by S-adenosylmethionone (SAM) in blood
Time Frame
Baseline to end of intervention (week 16)
Title
Change in Betaine levels in the Mitocholine group compared to the Placebo group
Description
Assessed by Betine in blood
Time Frame
Baseline to end of intervention (week 16)
Title
Change in Choline levels in the Mitocholine group compared to the Placebo group
Description
Assessed by Choline in blood
Time Frame
Baseline to end of intervention (week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing to participate in the study and comply with its procedures. Able to give written informed consent. Adults aged 55 to 79 years, inclusive. Meet MCI criteria, based on the Peterson criteria (Peterson et al., 1999): Presence of a subjective memory complaint as assessed by MAC-Q (score >25). Objective evidence of cognitive impairment as assessed by MoCA (score ≥18 to ≤24). Absence of major depression as assessed by PHQ (score <10). Activities of daily living score males ≥4 females ≥7 Have a homocysteine level ≥11.0μmol/L (Smith D et al, 2018). Exclusion Criteria: Diagnosis of a major cognitive disorder (e.g. Alzheimer's or Parkinson's disease diagnoses; additionally, confirmation of a mini stroke (TIA) within the last 3 months would be an exclusionary condition). Participants who are pregnant or wish to become pregnant during the trial. Participants who are lactating and/or currently breastfeeding. Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator. Participants with active or a history of alcohol or substance abuse; (exclude elevated Gamma GT & clinically abnormal liver function test). Uncontrolled diabetes (or glycated haemoglobin >7% / 53 mmol/mol). Clinically significant heart, liver, or renal disease (at the discretion of the investigator). Have uncontrolled hypertension SBP > 160mmHg, DBP > 100mmHg). Participants prescribed medications likely to influence memory or mood, as determined by the investigator. Participants with a history of depression (within past 24 months) or any concurrent medical, cognitive or psychiatric condition that would either: compromise his/her ability to comply with the study requirements, may pose significant risk to the participant, or be deemed exclusionary by the investigator Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results. Change in supplements, medication, or major diet in 30 days prior to enrolment and throughout the study. Taking any supplements or vitamins notably known to affect cognitive function (e.g. Living Nutrition Cognitive, Viridian Cognitive Complex, ginkgo biloba, fish oil etc., list not exhaustive), or any psychotropic medications and products which interact with acetylcholine esterase and/or NMDA receptors (6-week washout before screening). Vitamin D and Calcium supplements permitted if on a stable dose for the previous 3 months. Smokers (>5 cigs per week) or participants who use vape products. Has received treatment involving experimental drugs in the past 3 months. Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study. Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial. Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eile Butler
Phone
+353 21 430 7442
Email
ebutler@atlantiatrials.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Morrison
Organizational Affiliation
Mitocholine Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Atlantia Clinical Trials
City
Cork
State/Province
Munster
ZIP/Postal Code
T23R50R
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eile Butler
Phone
+353214307442
Email
ebutler@atlantiatrials.com
First Name & Middle Initial & Last Name & Degree
Timothy Dinan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Healthy Adults With Mild Cognitive Impairment (MCI) and a 16-week Intervention With Mitocholine™, a Functional Food Ingredient

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