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

C

Chung Shan Medical University

Status

Completed

Conditions

Alzheimer Disease
H Pylori Infection

Treatments

Other: Placebo
Dietary Supplement: Black raspberry

Study type

Interventional

Funder types

Other

Identifiers

NCT05680532
CS2-21103

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

21 participants in 2 patient groups, including a placebo group

BR group
Experimental group
Description:
Experimental group AZ subjects were requested to take 50 g of BR powder dissolved in 240 ml of water for 4 weeks.
Treatment:
Dietary Supplement: Black raspberry
Placebo group
Placebo Comparator group
Description:
Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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