Clinical trial NCT05406648: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Yuksek Ihtisas University
name: Gulhane Training and Research Hospital
First posted: 2022-06-06
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in cognition (ADAS-Cog)
timeFrame: 12 weeks
measure: Change in cognition (MMSE)
timeFrame: 12 weeks
measure: Antioxidant capacity (TOS)
timeFrame: 12 weeks
measure: Antioxidant capacity (TAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Zeynep Goktas, PhD
role: PRINCIPAL_INVESTIGATOR
References: