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

NCT05406648 | Completed

• 1 other identifier: 18-AKD-167
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

20g of Morus nigra concentrate administration for 12 weeks

Other: Morus nigra concentrate

Control

NO INTERVENTION

No intervention throughout the study

Interventions

Morus nigra concentrate OTHER

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Yuksek Ihtisas University: collaborator
• Gulhane Training and Research Hospital: collaborator

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zeynep Goktas, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: January 8, 2019
• Primary Completion: March 17, 2020
• Study Completion: January 28, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)