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

December 23, 2022 updated by: Chin Kun Wang, Chung Shan Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taichung
      • Taichung city, Taichung, Taiwan, 40201
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BR group
Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks.
Dietary supplement: Black raspberry
Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.
Placebo Comparator: Placebo group
Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.
Other: Placebo
Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic indices
Time Frame: 8 weeks
No significant changes in any of the glycemic indices
8 weeks
Anthropometric parameters
Time Frame: 8 weeks
BMI were significantly altered
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Chin-Kun Wang, Ph.D, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

June 5, 2022

Study Completion (Actual)

August 4, 2022

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS2-21103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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