NCT05680532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

December 7, 2022

Last Update Submit

December 23, 2022

Conditions

Keywords

black raspberryAlzheimer's patientsH pyloriInflammatory cytokinesAntioxidant

Outcome Measures

Primary Outcomes (2)

  • Glycemic indices

    No significant changes in any of the glycemic indices

    8 weeks

  • Anthropometric parameters

    BMI were significantly altered

    8 weeks

Study Arms (2)

BR group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Placebo group AZ subjects were requested to take 50 g of dextrin powder dissolved in 240 ml of water for 4 weeks.

Other: Placebo

Interventions

Black raspberryDIETARY_SUPPLEMENT

Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.

BR group
PlaceboOTHER

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

Placebo group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, Taichung, 40201, Taiwan

Location

Related Publications (1)

  • Tandoro Y, Chiu HF, Tan CL, Hsieh MH, Huang YW, Yu J, Wang LS, Chan CH, Wang CK. Black raspberry supplementation on overweight and Helicobacter pylori infected mild dementia patients a pilot study. NPJ Sci Food. 2025 Feb 12;9(1):9. doi: 10.1038/s41538-024-00356-w.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Chin-Kun Wang, Ph.D

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 11, 2023

Study Start

November 11, 2021

Primary Completion

June 5, 2022

Study Completion

August 4, 2022

Last Updated

January 11, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations