Effects of Green Tea Extracts on Gastric Mucosal Protection

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Functional Dyspepsia

Treatments: Dietary Supplement: Green tea combined extracts group; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT04742985

02-2020-048

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Green tea combined extracts group A

Experimental group

Description:

This group takes Green tea combined extracts (62.5 mg) for 8 weeks.

Treatment:

Dietary Supplement: Green tea combined extracts group

Green tea combined extracts group B

Experimental group

Description:

This group takes Green tea combined extracts (125 mg) for 8 weeks.

Treatment:

Dietary Supplement: Green tea combined extracts group

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 8 weeks.

Treatment:

Dietary Supplement: Placebo group