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| Name | Class |
|---|---|
| Yuksek Ihtisas University | OTHER |
| Gulhane Training and Research Hospital | OTHER_GOV |
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The study was conducted with 44 patients who were diagnosed with mild-to-moderate Alzheimer's Disease. Participants were divided into 2 groups intervention group and the control group. The intervention group was administered 20 grams of black mulberry concentrate per day for 12 weeks and the control group received no intervention thorough the study. Cognitive functions, antioxidant capacity, and inflammation markers were evaluated at the baseline and at the end of the 12 weeks.
The purpose of this study is to investigate the effects of black mulberry on cognitive functions and biochemical parameters in patients with Alzheimer's disease. The study was conducted in a tertiary geriatric outpatient clinic with 44 patients aged over 65 years who were diagnosed with mild-to-moderate AD. The study was completed by 20 participants in the intervention group and 19 participants in the control group. The intervention group was administered 20 grams of black mulberry concentrate per day for 12 weeks. There was no intervention in the control group (n=19). Routine medical treatment for all participants was continued throughout the study. During the evaluation of the cognitive situation, Mini-Mental State Assessment (MMSA) and AD Assessment Scale-Cognitive Subscale (ADAS-Cog) test were administered. Geriatric Depression Scale (GDS-15) was used to screen for depression symptoms. In order to evaluate antioxidant capacity in serum samples Superoxide dismutase (SOD) enzyme, Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and oxidative stress index level were examined. Furthermore, in order to evaluate lipid oxidation, Malondialdehyde (MDA) level was examined. For the evaluation of inflammation, serum Interleukin 1-beta (IL-1 beta) and Transforming growth factor-beta (TGF-beta) levels were measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 20g of Morus nigra concentrate administration for 12 weeks |
|
| Control | No Intervention | No intervention throughout the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morus nigra concentrate | Other | The experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognition (ADAS-Cog) | Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale scores | 12 weeks |
| Change in cognition (MMSE) | Change in Mini-Mental State Examination scores | 12 weeks |
| Antioxidant capacity (TOS) | Change in serum Total Oxidant Status (TOS) | 12 weeks |
| Antioxidant capacity (TAS) | Change in serum Total Antioxidant Status (TOS) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Those under 65 years of age
Those who have taken new dementia medication in the last 3 months
Those staying in nursing homes
Those with mild cognitive impairment who have not yet been diagnosed with dementia
Those who have cancer
Those with inflammatory diseases (viral or bacterial)
History of head trauma that may lead to unconsciousness or other neurological diseases other than dementia
Those with a defined autoimmune disease
Alcohol and drug addiction
Those with major depression
Those with uncontrollable hypertension
Those with uncontrolled diabetes
Those with dysphagia
Tube fed
Those who are bedridden
Delirium
Those who use drugs that may affect outcome measures, such as benzodiazepines
Due to the risk that black mulberry may cause possible food-drug interaction via p-glycoprotein / CYP3A in the literature, patients using the drugs named below will not be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Zeynep Goktas, PhD | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |