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

NCT05690724 | Unknown

• 1 other identifier: AFCRO-155
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline to end of intervention (week 16)

• Absolute change in Homocysteine levels in the Mitocholine group compared to the Placebo group.

  Assessed by serum Homocysteine levels (umol/L)

  Baseline to end of intervention (week 16)

Secondary Outcomes (6)

• Change in Choline levels in the Mitocholine group compared to the Placebo group

  Baseline to end of intervention (week 16)

• Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group

  Baseline to end of intervention (week 16)

• Change in Betaine levels in the Mitocholine group compared to the Placebo group

  Baseline to end of intervention (week 16)

• Change in Memory outcomes (visual memory) in the Mitocholine group compared to the Placebo group

  Baseline to end of intervention (week 16)

• Change in Memory outcomes (episodic memory) in the Mitocholine group compared to the Placebo group

  Baseline to end of intervention (week 16)

Study Arms (2)

Mitocholine™

EXPERIMENTAL

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

Dietary Supplement: Mitocholine™ or Placebo

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Mitocholine™ or Placebo

Interventions

Mitocholine™ or Placebo DIETARY_SUPPLEMENT

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.

Mitocholine™; Placebo

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Objective evidence of cognitive impairment as assessed by MoCA (score ≥18 to ≤25).
• 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).

You may not qualify if:

• 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.
• 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.
• Users of inhaled nicotine products such as cigarettes or vape products with an inconsistent recent history of consumption i.e., those who have taken up smoking/vaping in the 12 months prior to screening, or those who have either given up or re-started smoking or vaping in the 12 months prior to screening, or those who intend to significantly modify their use of inhaled nicotine products during their participation in the study.
• 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.

Sponsors & Collaborators

• Mitocholine Ltd: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, Munster, T23R50R, Ireland

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Steve Morrison

  Mitocholine Ltd

  STUDY DIRECTOR

Central Study Contacts

Eile Butler

CONTACT

+353 21 430 7442; ebutler@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double-blinded, placebo-controlled, parallel proof of concept study

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 19, 2023
• Study Start: January 9, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 18, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)