The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions and Antioxidant Capacity in Individuals Diagnosed With Dementia

Conditions
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Alzheimer Disease, Early Onset

Intervention / Treatment
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* Other: Morus nigra concentrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be diagnosed with dementia in the first stage To be using the same medication for dementia throughout the study To have been taking the same dementia medication for the last 6 months and no dose changes for at least 3 months Not to have used anthocyanin supplement regularly in the last four months before participating in the study Confirmation of medication use by caregivers To have a caregiver to follow the patient's daily intake of black mulberry concentrate 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. Antineoplastic drugs (docetaxel, etoposide, vincristine), Calcium channel blockers (eg amlodipine) Calcineurin inhibitors (tacrolimus and cyclosporine) Digoxin Macrolide antibiotics (Clarithromycin) Protease inhibitors

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>20g of Morus nigra concentrate administration for 12 weeks | Other: Morus nigra concentrate<br>* The experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks.<br>|
| No Intervention: Control<br>No intervention throughout the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |