Clinical trial NCT06313814: The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
Official title: The Effect of Ginger on Functional Dyspepsia Symptoms and Body Fat Content Among Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Functional Dyspepsia
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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:

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: lemgmed@yahoo.com
2. Dr. Zoltán Csiki, Supervisor Gastroenterologist DE Medical and Health Sciences Center Department: Institute of Internal Medicine - III. s. Department of Internal Medicine Email: csikiz@gmail.com

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 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.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from Functional dyspepsia symptoms

Exclusion Criteria:

* Patients with relevant gastroesophageal reflux symptoms (retrosternal pain, burning, or regurgitation) as well as patients with clear evidence of irritable bowel syndrome will not be included. Patients under treatment with pharmacological substances that could influence the gastrointestinal system, such as prokinetics, ursodeoxycholic acid (UDCA), nonsteroidal anti-inflammatory drugs (NSAIDs), cholagogues, protonpump inhibitors, and H2 blockers, will be asked to interrupt this treatment for one month before starting the study treatment.

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.

Primary outcomes:
measure: Functional Dyspepsia Symptom Severity
timeFrame: four weeks
measure: Body Fat Content Analysis
timeFrame: Four weeks
Secondary outcomes:
measure: Improvement in Quality of Life
timeFrame: Four weeks
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen
Study officials:
References: