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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alzheimer Disease, H Pylori Infection

Intervention / Treatment
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* Dietary Supplement: Black raspberry
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BR group<br>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<br>* Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.<br>|
| Placebo Comparator: Placebo group<br>Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks. | Other: Placebo<br>* Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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black raspberry, Alzheimer's patients, H pylori, Inflammatory cytokines, Antioxidant