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

Hacettepe University

Status

Completed

Conditions

Alzheimer Disease, Early Onset

Treatments

Other: Morus nigra concentrate

Study type

Interventional

Funder types

Other

Identifiers

NCT05406648

18-AKD-167

Details and patient eligibility

About

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.

Full description

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.

Enrollment

44 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.
1. Antineoplastic drugs (docetaxel, etoposide, vincristine),
2. Calcium channel blockers (eg amlodipine)
3. Calcineurin inhibitors (tacrolimus and cyclosporine)
4. Digoxin
5. Macrolide antibiotics (Clarithromycin)
6. Protease inhibitors