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

Alzheimer Disease, Early Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406648
• Other study ID #: 18-AKD-167
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: January 28, 2021

Study information

• Verified date: June 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 28, 2021
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Hacettepe University	Gulhane Training and Research Hospital, Yuksek Ihtisas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition (ADAS-Cog)	Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale scores	12 weeks
Primary	Change in cognition (MMSE)	Change in Mini-Mental State Examination scores	12 weeks
Primary	Antioxidant capacity (TOS)	Change in serum Total Oxidant Status (TOS)	12 weeks
Primary	Antioxidant capacity (TAS)	Change in serum Total Antioxidant Status (TOS)	12 weeks