Effects of Green Tea Extracts on Gastric Mucosal Protection

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742985
• Other study ID #: 02-2020-048
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Dietary Supplement:
• Green tea combined extracts group
Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
• Placebo group
Placebo 320 mg/day during 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	concentration of interferon-? (pg/mL)	interferon-? (pg/mL) measured at baseline and after 8 weeks	8 weeks
Secondary	concentration of tumor necrosis factor-a (pg/mL)	interferon-? (pg/mL) measured at baseline and after 8 weeks measured at baseline and after 8 weeks	8 weeks
Secondary	concentration of gastrin (pg/mL)	gastrin (pg/mL) measured at baseline and after 8 weeks	8 weeks
Secondary	concentration of malondialdehyde (mic·mol/L)	malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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