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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitocholine⢠| Experimental | Mitocholine⢠is a novel formulation of three nutrients choline, succinic acid, and nicotinamide (a vitamin B3) |
|
| Placebo | Placebo Comparator | The Placebo product will be identical in appearance and taste to the investigational product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Choline levels in the Mitocholine group compared to the Placebo group | Assessed by Choline in blood | Baseline to end of intervention (week 16) |
| Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group |
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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):
Objective evidence of cognitive impairment as assessed by MoCA (score ā„18 to ā¤25).
Absence of major depression as assessed by PHQ (score <10).
Activities of daily living score
Have a homocysteine level ā„11.0μmol/L (Smith D et al, 2018).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eile Butler | Contact | +353 21 430 7442 | ebutler@atlantiatrials.com |
| Name | Affiliation | Role |
|---|---|---|
| Steve Morrison | Mitocholine Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials | Recruiting | Cork | Munster | T23R50R | Ireland |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Randomised, double-blinded, placebo-controlled, parallel proof of concept study
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Assessed by S-adenosylmethionone (SAM) in blood |
| Baseline to end of intervention (week 16) |
| Change in Betaine levels in the Mitocholine group compared to the Placebo group | Assessed by Betine in blood | Baseline to end of intervention (week 16) |
| Change in Memory outcomes (visual memory) in the Mitocholine group compared to the Placebo group | Assessed by a Paired Associated Learning Task | Baseline to end of intervention (week 16) |
| Change in Memory outcomes (episodic memory) in the Mitocholine group compared to the Placebo group | Assessed by a Word Recall Task | Baseline to end of intervention (week 16) |
| Change in Language outcomes in the Mitocholine group compared to the Placebo group | Assessed by the Boston Naming Test | Baseline to end of intervention (week 16) |