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

Not Applicable

Completed

• Conditions: Alzheimer Disease; H Pylori Infection
• Interventions: Dietary Supplement: Black raspberry; Other: Placebo

• Registration Number: NCT05680532
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2021-11-11
• Primary Completion: 2022-06-05
• Study Completion: 2022-08-04
• Status Verified: 2022-12
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2023-01-11
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BR group	Black raspberry	Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks.
Placebo group	Placebo	Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Glycemic indices	8 weeks	No significant changes in any of the glycemic indices
Anthropometric parameters	8 weeks	BMI were significantly altered

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung city, Taichung, Taiwan