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.
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 to evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment. The primary hypotheses being that there will be a significant change in Executive Function scores as measured by Delis Kaplan Executive Function Score (DKEFS) and in homocysteine levels. The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
100
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.
Atlantia Clinical Trials
Cork, Munster, Ireland
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 (Composite Score)
Time frame: 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)
Time frame: Baseline to end of intervention (week 16)
Change in Choline levels in the Mitocholine group compared to the Placebo group
Assessed by Choline in blood
Time frame: Baseline to end of intervention (week 16)
Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group
Assessed by S-adenosylmethionone (SAM) in blood
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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 (spontaneous responses and total correct responses)
Time frame: Baseline to end of intervention (week 16)
Change in individual verbal and non-verbal Executive Function Scores in the Mitocholine group compared to the Placebo group.
Assessed by individual tests within the DKEFS battery
Time frame: Baseline to end of intervention (week 16)
Evaluate the effect of consumption of Mitocholine on blood markers of insulin sensitivity
Assessed by Glucose levels
Time frame: Baseline to end of intervention (week 16)
Evaluate the effect of consumption of Mitocholine on blood markers of insulin sensitivity
Assessed by insulin levels
Time frame: Baseline to end of intervention (week 16)