Effects of Green Tea Extracts on Gastric Mucosal Protection

Study Overview
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Brief Summary
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The investigators conduct a randomized, double-blind, placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional dyspepsia for 8 weeks.

Detailed Description
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A previous study has indicated that combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) may improve gastric mucosal status in rat with alcohol-induced gastritis.Therefore, the investigators conduct a randomized, double-blind, placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional dyspepsia for 8 weeks; the safety of the compound are also evaluated. The Investigators examine C-reactive protein, IFN-γ, TNF-α, gastrin, malondialdehyde, 8-hydroxy-2' -deoxyguanosine, and questionnaires (Gastrointestinal Symptom Rating Scale, Nepean dyspepsia index-Korean version, Nepean dyspepsia index-Korean version QOL questionnaire, Gastrointestinal symptom scale) at baseline and after 8 weeks of intervention. Twenty four adults were administered either 320 mg of combined extracts of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) or a placebo each day for 8 weeks.

Official Title
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Effects of Combined Extracts of Green Tea Seed (Saponins) and Green Tea Leaves (Epigallocatechin-3-gallate) on Gastric Mucosal Protection: A Pilot Study

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Green tea combined extracts group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Rome IV criteria define dyspepsia as any combination of 4 symptoms: postprandial fullness, early satiety, epigastric pain, and epigastric burning that are severe enough to interfere with the usual activities and occur at least 3 days per week over the last 3 months Exclusion Criteria: Patients complaining of severe gastrointestinal symptoms requiring immediate medication Those with a history of gastric acid hypersecretion such as Zollinger-Ellison Syndrome Those who received Helicobacter pylori eradication therapy within 4 weeks Those who have taken nonsteroidal anti-inflammatory drugs, steroid drugs or antibiotics, aspirin or antithrombotic drugs, or gastric acid suppressants within 4 weeks Those who have a history of upper gastrointestinal tract surgery, stenosis, bleeding, esophageal dilatation, gastric mucosal resection, etc. within the past 1 year Patients with gastric ulcer (active or healing), duodenal ulcer (active or healing), reflux esophagitis (LA B or higher), or malignant tumors from gastroscopy performed within the last 6 months Abnormal liver or renal function (more than twice the normal upper limit of the research institute) Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar) History of fracture during the previous year Uncontrolled hypertension (>160/100 mmHg) Uncontrolled thyroid diseases. History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months History of any central bone fracture within 1 year History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication. Alcohol abuser Allergic reaction to Ishige Okamurae Those who participated in other drug clinical trials within 1 month from the screening date. Severe gastrointestinal symptoms such as heartburn and indigestion Those who are pregnant, lactating, or plan to become pregnant during the clinical trial Those who are judged to be unsuitable by the PI for other reasons

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green tea combined extracts group A<br>This group takes Green tea combined extracts (62.5 mg) for 8 weeks. | Dietary Supplement: Green tea combined extracts group<br>* Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks<br>|
| Experimental: Green tea combined extracts group B<br>This group takes Green tea combined extracts (125 mg) for 8 weeks. | Dietary Supplement: Green tea combined extracts group<br>* Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes placebo for 8 weeks. | Dietary Supplement: Placebo group<br>* Placebo 320 mg/day during 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale (score) | Gastrointestinal Symptom Rating Scale - questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 75. A higher score indicates a worse outcome. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of high-sensitivity C-reactive protein (mg/L) | high-sensitivity C-reactive protein (mg/L) measured at baseline and after 8 weeks | 8 weeks | 
| concentration of interferon-γ (pg/mL) | interferon-γ (pg/mL) measured at baseline and after 8 weeks | 8 weeks | 
| concentration of tumor necrosis factor-α (pg/mL) | interferon-γ (pg/mL) measured at baseline and after 8 weeks measured at baseline and after 8 weeks | 8 weeks | 
| concentration of gastrin (pg/mL) | gastrin (pg/mL) measured at baseline and after 8 weeks | 8 weeks | 
| concentration of malondialdehyde (mic·mol/L) | malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks | 8 weeks | 
| concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) | 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) measured at baseline and after 8 weeks | 8 weeks | 
| Nepean dyspepsia index-Korean version (score) | Nepean dyspepsia index-Korean version - questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 195. A higher score indicates a worse outcome. | 8 weeks | 
| Nepean dyspepsia index-Korean version QOL questionnaire (score) | Nepean dyspepsia index-Korean version QOL questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 125. A higher score indicates a worse outcome. | 8 weeks | 
| Gastrointestinal symptom scale (score) | Gastrointestinal symptom scale questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 40. A higher score indicates a worse outcome. | 8 weeks |