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

Alzheimer Disease Clinical Trial

— BR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680532
• Other study ID #: CS2-21103
• Status: Completed
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: August 4, 2022

Study information

• Verified date: December 2022
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 4, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• H Pylori Infection

Intervention

Dietary Supplement:
• Black raspberry
Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.

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

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung city	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic indices	No significant changes in any of the glycemic indices	8 weeks
Primary	Anthropometric parameters	BMI were significantly altered	8 weeks