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Effects of Green Tea Extracts on Gastric Mucosal Protection

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Green tea combined extracts group
Placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Green tea combined extracts group A

Green tea combined extracts group B

Placebo group

Arm Description

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

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

This group takes placebo for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

concentration of high-sensitivity C-reactive protein (mg/L)
high-sensitivity C-reactive protein (mg/L) measured at baseline and after 8 weeks
concentration of interferon-γ (pg/mL)
interferon-γ (pg/mL) measured at baseline and after 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
concentration of gastrin (pg/mL)
gastrin (pg/mL) measured at baseline and after 8 weeks
concentration of malondialdehyde (mic·mol/L)
malondialdehyde (mic·mol/L) measured at baseline and after 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
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.
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.
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.

Full Information

First Posted
February 3, 2021
Last Updated
July 30, 2021
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04742985
Brief Title
Effects of Green Tea Extracts on Gastric Mucosal Protection
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green tea combined extracts group A
Arm Type
Experimental
Arm Description
This group takes Green tea combined extracts (62.5 mg) for 8 weeks.
Arm Title
Green tea combined extracts group B
Arm Type
Experimental
Arm Description
This group takes Green tea combined extracts (125 mg) for 8 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea combined extracts group
Intervention Description
Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Placebo 320 mg/day during 8 weeks
Primary Outcome Measure Information:
Title
Gastrointestinal Symptom Rating Scale (score)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
concentration of high-sensitivity C-reactive protein (mg/L)
Description
high-sensitivity C-reactive protein (mg/L) measured at baseline and after 8 weeks
Time Frame
8 weeks
Title
concentration of interferon-γ (pg/mL)
Description
interferon-γ (pg/mL) measured at baseline and after 8 weeks
Time Frame
8 weeks
Title
concentration of tumor necrosis factor-α (pg/mL)
Description
interferon-γ (pg/mL) measured at baseline and after 8 weeks measured at baseline and after 8 weeks
Time Frame
8 weeks
Title
concentration of gastrin (pg/mL)
Description
gastrin (pg/mL) measured at baseline and after 8 weeks
Time Frame
8 weeks
Title
concentration of malondialdehyde (mic·mol/L)
Description
malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks
Time Frame
8 weeks
Title
concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein)
Description
8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) measured at baseline and after 8 weeks
Time Frame
8 weeks
Title
Nepean dyspepsia index-Korean version (score)
Description
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.
Time Frame
8 weeks
Title
Nepean dyspepsia index-Korean version QOL questionnaire (score)
Description
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.
Time Frame
8 weeks
Title
Gastrointestinal symptom scale (score)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Green Tea Extracts on Gastric Mucosal Protection

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