Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313814
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-12
First Post:
2024-02-21
Brief Title:
The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
Sponsor:
University of Debrecen
Organization:
University of Debrecen
Study Overview
Official Title:
The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess gingers effect on patients with functional dyspepsia
The main questions it aims to answer are
1 Does ginger intake improve functional dyspepsia symptoms
2 Does ginger intake decrease the body fat content among patients with functional dyspepsia Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day Researchers will assess if there is an improvement in the symptoms of the disease and the fat content to see if gingers effect
The main questions it aims to answer are
1 Does ginger intake improve functional dyspepsia symptoms
2 Does ginger intake decrease the body fat content among patients with functional dyspepsia Dyspepsia patients will be asked to take 540 mg of ginger capsule twice a day Researchers will assess if there is an improvement in the symptoms of the disease and the fat content to see if gingers effect
Detailed Description:
Brief description of the study
Currently the options for managing functional dyspepsia are limited and far from ideal Few conducted studies showed that ginger consumption has a therapeutic and preventive effect on functional dyspepsia however the results were not conclusive Therefore this study will try to investigate the effect of ginger supplementation on functional dyspepsia symptoms and body fat content among patients with Functional dyspepsia
Volunteers with functional dyspepsia 62 participants will be will take as tablets containing 540mg ginger capsule twice a day for four weeks with follow-up Functional dyspepsia symptoms will be asked before and after the intervention using a questionnaire based on the symptoms of Rome IV criteria including gastric fullness early satiety nausea vomiting belching epigastric pain and heartburn which will be graded through visual analog scales 0- 10 scores and measured for the body contents
Method and Materials
Sample size sample selection
The study will include 62 volunteers with functional dyspepsia female and male participants between the ages of 18 and 72 years
Study design This study is a before-after interventional study of patients with functional dyspepsia who come to internal medicine at the University of Debrecen
Initiator of the investigation
Mrs Lemlem Gebremariam Aregawi PhD student in Nutritional sciences Dr Zoltán Csiki Supervisor
Executor of the study
1 Mrs Lemlem Gebremariam Aregawi PhD student in Nutritional sciences Doctoral school of pharmacology and pharmacotherapy University of Debrecen Tel- 36204027611 E-mail lemgmedyahoocom
2 Dr Zoltán Csiki Supervisor Gastroenterologist DE Medical and Health Sciences Center Department Institute of Internal Medicine - III s Department of Internal Medicine Email csikizgmailcom
Test site
University of Debrecen OEC Institute of Internal Medicine - III s Clinic of Internal Medicine
Form and process of the examination
The examination is performed by a specialist gastroenterologist and nutrition student of the Institute of Internal Medicine with the help of section assistants familiar with the in-body measurement to measure body minerals fat muscle water and BMI
In the case of each person examined a form is filled in which is also recorded in electronic form The results of the physical examination of this participant as well as the measured results will be recorded
Body composition analyzer InBody720 Patient requirements to be included empty stomach empty bladder light clothes and no shoes for measurement in the early morning on the body composition analyzer Patients with a pacemaker or with metal in the body will be excluded from measurement on this instrument
Dosage Volunteers will take 540mg of ginger capsule twice a day for four weeks
Dosage Attached In a separate dossier for each surveyed consumer a statement of consent
Design of the study before and after the interventional study Study subject volunteer consumers men women 18 - 72 years
Meals
Diet intervention- 100 ginger powder ground 540mg capsule twice a day dose will be used each component is characterized by elevated stability It is prepared using extraction procedures suitable for ingredients of the health food market The capsule will be provided free of charge and specifically designed for this study
All patients will be instructed to take one capsule immediately before starting lunch and dinner During 30 days before the beginning of the study and the 28 days of intervention treatment all patients will be asked to avoid the use of prokinetic and antisecretory H2 receptor inhibitors and proton pump inhibitors drugs All patients will be also asked to limit the consumption of alcoholic beverages less than or equal to two drinks per day
Study group Study group 62 FD patients Response variables Dependent variables
functional dyspepsia symptoms
body contents muscle fat minerals and water
Task details
Preparation recruitment of consumers and selection of participants
Signing of prospectuses and statements of consent
Carry out a preliminary examination among the applicants Before
Self-completion questionnaire
Performing in-body tests
Evaluation of results
Data analysis method
Data will be analyzed using SPSS software version 230 IBM Corp Armonk NY USA Results will be reported as mean SD and median IQR The Wilcoxon signed rank test will be used to assess the differences in GI symptoms before and after ginger supplementation The difference between the concentrations at the given time points initial concentration will be calculated the statistical procedure being the repeat t-test If the background variables become inhomogeneous it may be necessary to include covariates in the statistical analysis in which case covariance analysis will be used If the normality of the data is not adequate for the test or a normal data distribution cannot be transformed the non-parametric test will be used We will examine whether the measured parameters change significantly The significance level will be set at P 005
Currently the options for managing functional dyspepsia are limited and far from ideal Few conducted studies showed that ginger consumption has a therapeutic and preventive effect on functional dyspepsia however the results were not conclusive Therefore this study will try to investigate the effect of ginger supplementation on functional dyspepsia symptoms and body fat content among patients with Functional dyspepsia
Volunteers with functional dyspepsia 62 participants will be will take as tablets containing 540mg ginger capsule twice a day for four weeks with follow-up Functional dyspepsia symptoms will be asked before and after the intervention using a questionnaire based on the symptoms of Rome IV criteria including gastric fullness early satiety nausea vomiting belching epigastric pain and heartburn which will be graded through visual analog scales 0- 10 scores and measured for the body contents
Method and Materials
Sample size sample selection
The study will include 62 volunteers with functional dyspepsia female and male participants between the ages of 18 and 72 years
Study design This study is a before-after interventional study of patients with functional dyspepsia who come to internal medicine at the University of Debrecen
Initiator of the investigation
Mrs Lemlem Gebremariam Aregawi PhD student in Nutritional sciences Dr Zoltán Csiki Supervisor
Executor of the study
1 Mrs Lemlem Gebremariam Aregawi PhD student in Nutritional sciences Doctoral school of pharmacology and pharmacotherapy University of Debrecen Tel- 36204027611 E-mail lemgmedyahoocom
2 Dr Zoltán Csiki Supervisor Gastroenterologist DE Medical and Health Sciences Center Department Institute of Internal Medicine - III s Department of Internal Medicine Email csikizgmailcom
Test site
University of Debrecen OEC Institute of Internal Medicine - III s Clinic of Internal Medicine
Form and process of the examination
The examination is performed by a specialist gastroenterologist and nutrition student of the Institute of Internal Medicine with the help of section assistants familiar with the in-body measurement to measure body minerals fat muscle water and BMI
In the case of each person examined a form is filled in which is also recorded in electronic form The results of the physical examination of this participant as well as the measured results will be recorded
Body composition analyzer InBody720 Patient requirements to be included empty stomach empty bladder light clothes and no shoes for measurement in the early morning on the body composition analyzer Patients with a pacemaker or with metal in the body will be excluded from measurement on this instrument
Dosage Volunteers will take 540mg of ginger capsule twice a day for four weeks
Dosage Attached In a separate dossier for each surveyed consumer a statement of consent
Design of the study before and after the interventional study Study subject volunteer consumers men women 18 - 72 years
Meals
Diet intervention- 100 ginger powder ground 540mg capsule twice a day dose will be used each component is characterized by elevated stability It is prepared using extraction procedures suitable for ingredients of the health food market The capsule will be provided free of charge and specifically designed for this study
All patients will be instructed to take one capsule immediately before starting lunch and dinner During 30 days before the beginning of the study and the 28 days of intervention treatment all patients will be asked to avoid the use of prokinetic and antisecretory H2 receptor inhibitors and proton pump inhibitors drugs All patients will be also asked to limit the consumption of alcoholic beverages less than or equal to two drinks per day
Study group Study group 62 FD patients Response variables Dependent variables
functional dyspepsia symptoms
body contents muscle fat minerals and water
Task details
Preparation recruitment of consumers and selection of participants
Signing of prospectuses and statements of consent
Carry out a preliminary examination among the applicants Before
Self-completion questionnaire
Performing in-body tests
Evaluation of results
Data analysis method
Data will be analyzed using SPSS software version 230 IBM Corp Armonk NY USA Results will be reported as mean SD and median IQR The Wilcoxon signed rank test will be used to assess the differences in GI symptoms before and after ginger supplementation The difference between the concentrations at the given time points initial concentration will be calculated the statistical procedure being the repeat t-test If the background variables become inhomogeneous it may be necessary to include covariates in the statistical analysis in which case covariance analysis will be used If the normality of the data is not adequate for the test or a normal data distribution cannot be transformed the non-parametric test will be used We will examine whether the measured parameters change significantly The significance level will be set at P 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None