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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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The objective of the study is to test the capacity of acute and chronic supplementations of Turmipure GOLD® to improve cognitive performance in healthy aging
The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the short- and long-term improvement of cognitive functions, including memory and attention, in subjects with age-associated memory impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPG | Experimental | 76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 24 weeks |
|
| Control | Placebo Comparator | 76 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (colored acacia gum) product during 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turmipure Gold® | Dietary Supplement | TPG: Turmipure GOLD® - 1 capsule per day - as prescribed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance through Quality of Working memory | Quality of Working memory is a composite score determined by the CDR System™ test battery (unit: #) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance through Power of Attention | Power of Attention is a composite score determined by the CDR System™ test battery (unit: ms) | 24 weeks |
| Change in cognitive performance through Continuity of Attention |
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Inclusion Criteria:
Consent to the study and willing/able to comply with study product
Males and females aged ≥ 60 and ≤ 85 years old
Participants with subjective memory impairment, with preserved global cognitive functions, everyday activities, and no dementia, fulfilling age-associated memory impairment criteria based on the following National Institute of Mental Health criteria (AAMI, Crook 1986):
Not suffering from depression or anxiety, as determined by the Hospital Anxiety and Depression Scale (HADs) score of ≤7 for both depression and anxiety
With a BMI between 18 and 32 kg/m²
With a glycated haemoglobin/A1C score ≤ 5.7 %
Willing to maintain existing dietary, body weight, and physical activity patterns throughout the study period
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Dinan, Professor | Atlantia Food Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | T23 R50R | Ireland |
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| Placebo |
| Dietary Supplement |
Placebo: colored acacia gum - 1 capsule per day - as prescribed |
|
Continuity of Attention is a composite score determined by the CDR System™ test battery (unit: #)
| 24 weeks |
| Change in cognitive performance through Cognitive Reaction Time | Cognitive Reaction Time is a composite score determined by the CDR System™ test battery (unit: ms) | 24 weeks |
| Change in cognitive performance through Speed of Memory | Speed of Memory is a composite score determined by the CDR System™ test battery (unit: ms) | 24 weeks |
| Change in cognitive performance through Quality of Episodic Memory | Quality of Episodic Memory is a composite score determined by the CDR System™ test battery (unit: #) | 24 weeks |
| Change in cognitive performance through Quality of Memory | Quality of Memory is a composite score determined by the CDR System™ test battery (unit: #) | 24 weeks |
| Change in cognitive performance through Executive Function | Executive Function is a composite score determined by the CDR System™ test battery (unit: #) | 24 weeks |
| Change in stress | Stress will be assessed using the validated scale Perceived Stress Scale (0 to 56, higher scores meaning at maximum stress) | 24 weeks |
| Change in feelings and emotions | Mood will be assessed using the validated Positive and Negative Affect Schedule - Expanded Form (PANAS-X) questionnaire | 24 weeks |
| Change in mood | Mood will be assessed using the validated Bond-Lader questionnaire | 24 weeks |