The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori

NCT ID: NCT05680532

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-08-04

Brief Summary

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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

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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

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Alzheimer Disease H Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BR group

Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks.

Group Type EXPERIMENTAL

Black raspberry

Intervention Type DIETARY_SUPPLEMENT

Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.

Placebo group

Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.

Interventions

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Black raspberry

Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chin Kun Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin-Kun Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, Taichung, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 39939643 (View on PubMed)

Other Identifiers

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CS2-21103

Identifier Type: -

Identifier Source: org_study_id

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