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

NCT ID: NCT05406648

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2021-01-28

Brief Summary

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

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.

Conditions

Alzheimer Disease, Early Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

20g of Morus nigra concentrate administration for 12 weeks

Group Type: EXPERIMENTAL

Morus nigra concentrate

Intervention Type: OTHER

The experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks.

Control

No intervention throughout the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Morus nigra concentrate

The experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuksek Ihtisas University

OTHER

Sponsor Role: collaborator

Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Goktas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Goktas, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

18-AKD-167

Identifier Type: -

Identifier Source: org_study_id