Alzheimer DiseaseBRNCT05680532
The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori
A study testing Black raspberry in people with Alzheimer Disease and H Pylori Infection, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Alzheimer Disease, H Pylori Infection
- What is being tested?
- Black raspberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Nov 2021to 4 Aug 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≧ 27, Waist circumference: men ≧ 90cm, women ≧ 80cm,
- Body fat: male ≧ 25%, female ≧ 30%,
- UBT 13C test value> 10‰ (H. pylori (+)),
- CDR (clinical dementia rating) = 0.5
Who cannot join
- BMI< 27
- Severe chronic diseases (liver disease, cardiovascular disease, kidney disease)
- Alcohol abuse
- Smoking habit
- Taking berry-related supplementation or any known allergies related to berries.
- Subjects with prior history of H. pylori infection were treated with triple therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR.
Read the detailed description
The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).
Preclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the anti-adhesion activity of BR.
For the clinical trial, a total of 21 obese mild AZ patients were recruited and separated into 2 groups: Experimental (BR group) and Placebo group.
Experimental group and Placebo group subjects were requested to take either 50 g of BR or 50 g of dextrin respectively for 4 weeks.
- Conditions
- Alzheimer Disease, H Pylori Infection
- Being tested
- Black raspberry, Placebo
- Keywords
- black raspberry, Alzheimer's patients, H pylori, Inflammatory cytokines, Antioxidant
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black raspberryDietary supplement
Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.
PlaceboOther
Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BR group | Experimental | Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks. Receives: Dietary Supplement: Black raspberry |
| Placebo group | Placebo comparator | Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic indices
No significant changes in any of the glycemic indices
Measured: 8 weeks
Anthropometric parameters
BMI were significantly altered
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start11 Nov 2021
- Primary completion5 Jun 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Kun Wang, Chung Shan Medical University
- Investigators
- Chin-Kun Wang, Ph.D, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680532
- Sponsor's protocol ID
- CS2-21103
- Acronym
- BR
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tandoro Y, Chiu HF, Tan CL, Hsieh MH, Huang YW, Yu J, Wang LS, Chan CH, Wang CK. Black raspberry supplementation on overweight and Helicobacter pylori infected mild dementia patients a pilot study. NPJ Sci Food. 2025 Feb 12;9(1):9. doi: 10.1038/s41538-024-00356-w.
PubMed 39939643
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori
- ClinicalTrials.gov ID
- NCT05680532
- Acronym / sponsor ID
- BR / CS2-21103
- Conditions
- Alzheimer Disease, H Pylori Infection
- Keywords
- black raspberry, Alzheimer's patients, H pylori, Inflammatory cytokines, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 11 Jan 2023 (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 current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR.
Detailed description
The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).
Preclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the anti-adhesion activity of BR.
For the clinical trial, a total of 21 obese mild AZ patients were recruited and separated into 2 groups: Experimental (BR group) and Placebo group.
Experimental group and Placebo group subjects were requested to take either 50 g of BR or 50 g of dextrin respectively for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR group | Experimental | Dietary Supplement: Black raspberryExperimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≧ 27, Waist circumference: men ≧ 90cm, women ≧ 80cm,
- Body fat: male ≧ 25%, female ≧ 30%,
- UBT 13C test value> 10‰ (H. pylori (+)),
- CDR (clinical dementia rating) = 0.5
Key exclusion criteria (6 listed)
- BMI< 27
- Severe chronic diseases (liver disease, cardiovascular disease, kidney disease)
- Alcohol abuse
- Smoking habit
- Taking berry-related supplementation or any known allergies related to berries.
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 |
|---|---|---|
| Black raspberryExperimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks. | Dietary supplement | BR group |
| PlaceboPlacebo group subjects were requested to take 50 g of dextrin for 4 weeks. | Other | Placebo group |
Primary outcome
Glycemic indices
Time frame: 8 weeks
No significant changes in any of the glycemic indices
Anthropometric parameters
Time frame: 8 weeks
BMI were significantly altered
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 11 Jan 2023.
- Derived from this study: PubMed 39939643Tandoro Y, Chiu HF, Tan CL, Hsieh MH, Huang YW, Yu J, Wang LS, Chan CH, Wang CK. Black raspberry supplementation on overweight and Helicobacter pylori infected mild dementia patients a pilot study. NPJ Sci Food. 2025 Feb 12;9(1):9. doi: 10.1038/s41538-024-00356-w.
- 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.
Chin-Kun Wang, Ph.D principal investigator
Chung Shan Medical 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 Black raspberry in people with Alzheimer Disease and H Pylori Infection, run by Chung Shan Medical University at 1 site in Taiwan.
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 4 inclusion and 6 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 11 Jan 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Glycemic indices (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680532, which also lists 1 linked publication.
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 11 Jan 2023.