The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
The goal of this clinical trial is to assess ginger's effect on patients with functional dyspepsia.
The main question[s] it aims to answer are:
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:
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)
Task details:
Data analysis method:
Data will be analyzed using SPSS software, version 23.0 (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 = 0.05.
Inclusion Criteria:
Exclusion Criteria:
Moreover, patients with a previous diagnosis of cancer or with previous surgery of the upper gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy) and patients with active HP infection or with gastric or duodenal ulcer, as well as pregnant women, will be excluded.