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

Sponsor

Chung Shan Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05680532

Collaborator

(none)

Enrollment

Location

Arms

8.7

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease H Pylori Infection	Dietary Supplement: Black raspberry Other: Placebo	N/A

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

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 11, 2021

Actual Primary Completion Date :

Jun 5, 2022

Actual Study Completion Date :

Aug 4, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Glycemic indices [8 weeks]
No significant changes in any of the glycemic indices
Anthropometric parameters [8 weeks]
BMI were significantly altered

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung Shan Medical University	Taichung city	Taichung	Taiwan	40201

Sponsors and Collaborators

Chung Shan Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chin Kun Wang, Professor, Chung Shan Medical University

ClinicalTrials.gov Identifier:

NCT05680532

Other Study ID Numbers:

CS2-21103

First Posted:

Jan 11, 2023

Last Update Posted:

Jan 11, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Keywords provided by Chin Kun Wang, Professor, Chung Shan Medical University

black raspberry

Alzheimer's patients

H pylori

Inflammatory cytokines

Antioxidant

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Jan 11, 2023