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

Primary Purpose

Alzheimer Disease, Early Onset

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Morus nigra concentrate
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease, Early Onset

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

20g of Morus nigra concentrate administration for 12 weeks

No intervention throughout the study

Outcomes

Primary Outcome Measures

Change in cognition (ADAS-Cog)
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale scores
Change in cognition (MMSE)
Change in Mini-Mental State Examination scores
Antioxidant capacity (TOS)
Change in serum Total Oxidant Status (TOS)
Antioxidant capacity (TAS)
Change in serum Total Antioxidant Status (TOS)

Secondary Outcome Measures

Full Information

First Posted
June 1, 2022
Last Updated
June 3, 2022
Sponsor
Hacettepe University
Collaborators
Yuksek Ihtisas University, Gulhane Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05406648
Brief Title
The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions
Official Title
The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions and Antioxidant Capacity in Individuals Diagnosed With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Yuksek Ihtisas University, Gulhane Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Early Onset

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
20g of Morus nigra concentrate administration for 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention throughout the study
Intervention Type
Other
Intervention Name(s)
Morus nigra concentrate
Intervention Description
The experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks.
Primary Outcome Measure Information:
Title
Change in cognition (ADAS-Cog)
Description
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale scores
Time Frame
12 weeks
Title
Change in cognition (MMSE)
Description
Change in Mini-Mental State Examination scores
Time Frame
12 weeks
Title
Antioxidant capacity (TOS)
Description
Change in serum Total Oxidant Status (TOS)
Time Frame
12 weeks
Title
Antioxidant capacity (TAS)
Description
Change in serum Total Antioxidant Status (TOS)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. Antineoplastic drugs (docetaxel, etoposide, vincristine), Calcium channel blockers (eg amlodipine) Calcineurin inhibitors (tacrolimus and cyclosporine) Digoxin Macrolide antibiotics (Clarithromycin) Protease inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Goktas, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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