Alzheimer Disease, Early OnsetNCT05406648
The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions
A study testing Morus nigra concentrate in people with Alzheimer Disease, Early Onset, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- Morus nigra concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2019to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions and Antioxidant Capacity in Individuals Diagnosed With Dementia
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.
Read the 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
- Being tested
- Morus nigra concentrate
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morus nigra concentrateOther
The experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 20g of Morus nigra concentrate administration for 12 weeks Receives: Other: Morus nigra concentrate |
| Control | No intervention | No intervention throughout the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition (ADAS-Cog)
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale scores
Measured: 12 weeks
Change in cognition (MMSE)
Change in Mini-Mental State Examination scores
Measured: 12 weeks
Antioxidant capacity (TOS)
Change in serum Total Oxidant Status (TOS)
Measured: 12 weeks
Antioxidant capacity (TAS)
Change in serum Total Antioxidant Status (TOS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start8 Jan 2019
- Primary completion17 Mar 2020
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuksek Ihtisas University, Gulhane Training and Research Hospital
- Responsible party
- Principal investigator, Zeynep Goktas, Hacettepe University
- Investigators
- Zeynep Goktas, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406648
- Sponsor's protocol ID
- 18-AKD-167
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Black Mulberry (Morus Nigra) Consumption on Cognitive Functions and Antioxidant Capacity in Individuals Diagnosed With Dementia
- ClinicalTrials.gov ID
- NCT05406648
- Acronym / sponsor ID
- 18-AKD-167
- Conditions
- Alzheimer Disease, Early Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Yuksek Ihtisas University, Gulhane Training and Research Hospital
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Morus nigra concentrate20g of Morus nigra concentrate administration for 12 weeks |
| Control | No intervention | –No intervention throughout the study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morus nigra concentrateThe experimental group was given 20 grams of black mulberry (morus nigra) concentrate per day for 12 weeks. | Other | Intervention |
Primary outcome
Change in cognition (ADAS-Cog)
Time frame: 12 weeks
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale scores
Change in cognition (MMSE)
Time frame: 12 weeks
Change in Mini-Mental State Examination scores
Antioxidant capacity (TOS)
Time frame: 12 weeks
Change in serum Total Oxidant Status (TOS)
Antioxidant capacity (TAS)
Time frame: 12 weeks
Change in serum Total Antioxidant Status (TOS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Goktas, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morus nigra concentrate in people with Alzheimer Disease, Early Onset, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognition (ADAS-Cog) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.