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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MindMD Supplement | Experimental | Participants in the experimental group will receive the MindMD supplement, which contains the following ingredients: 600 mg Bacopa monnieri (Bacognize®), 250 mg Cognigrape® Grape Extract, 100 mg Phosphatidylserine, 50 mg Green Tea Leaf Extract, 1.7 mg Vitamin B6, and 200 mcg Folate (120 mcg folic acid). |
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| Placebo | Placebo Comparator | Participants in the placebo group will receive a placebo, which contains rice flour encapsulated in a vegetable cellulose capsule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MindMD Supplement | Dietary Supplement | Participants will take two capsules of the MindMD supplement once daily with their morning meal for a duration of 3 months. The supplement is designed to improve and maintain cognitive function and memory. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function and Memory Improvement | Measurement of cognitive function and memory through Cognitive Battery Testing. The Cognitive Battery Testing includes assessments such as Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, and Spatial Planning. These assessments provide objective measurements of various cognitive functions, including processing speed, memory recall, selective attention, and executive function. | Baseline, Month 2, and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire | Evaluation of participants' self-reported perceptions of the effect of the MindMD supplement on cognitive function and memory. This includes aspects such as focus and attentiveness, comprehension and mental clarity, learning acuity, absentmindedness, and overall quality of life. These perceptions will be measured through the Cognitive Function Questionnaire (CFQ) at specified time points: Baseline (Day 0), Month 1, Month 2, and Month 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Placebo | Other | Participants will take two capsules of the placebo once daily with their morning meal for a duration of 3 months. The placebo is designed to be indistinguishable in appearance and administration from the MindMD supplement to ensure blinding. |
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| Baseline, Month 1, Month 2, and Month 3 |
| Participants' Quality of Life | Assessment of participants' quality of life using the WHO-5 Well-Being Index. These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3. | Baseline, Month 1, Month 2, and Month 3 |
| Participants' Focus and Attentiveness | Evaluation of participants' focus and attentiveness using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3. | Baseline, Month 1, Month 2, and Month 3 |