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

Primary Purpose

Alzheimer Disease, H Pylori Infection

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Black raspberry

Placebo

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring black raspberry, Alzheimer's patients, H pylori, Inflammatory cytokines, Antioxidant

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chung Shan Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BR group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glycemic indices

No significant changes in any of the glycemic indices

Anthropometric parameters

BMI were significantly altered

Secondary Outcome Measures

Full Information

NCT ID

NCT05680532

First Posted

December 7, 2022

Last Updated

December 23, 2022

Sponsor

Chung Shan Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05680532

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

November 11, 2021 (Actual)

Primary Completion Date

June 5, 2022 (Actual)

Study Completion Date

August 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, H Pylori Infection

Keywords

black raspberry, Alzheimer's patients, H pylori, Inflammatory cytokines, Antioxidant

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BR group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Black raspberry

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Glycemic indices

Description

No significant changes in any of the glycemic indices

Time Frame

8 weeks

Title

Anthropometric parameters

Description

BMI were significantly altered

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chin-Kun Wang, Ph.D

Organizational Affiliation

Chung Shan Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chung Shan Medical University

City

Taichung city

State/Province

Taichung

ZIP/Postal Code

40201

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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