Effects of Green Tea Extracts on Gastric Mucosal Protection

July 30, 2021 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeungsangnam-do
      • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Green tea combined extracts group A
This group takes Green tea combined extracts (62.5 mg) for 8 weeks.
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
Experimental: Green tea combined extracts group B
This group takes Green tea combined extracts (125 mg) for 8 weeks.
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 Comparator: Placebo group
This group takes placebo for 8 weeks.
Dietary supplement: Placebo group
Placebo 320 mg/day during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Symptom Rating Scale (score)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
high-sensitivity C-reactive protein (mg/L) measured at baseline and after 8 weeks
8 weeks
concentration of interferon-γ (pg/mL)
Time Frame: 8 weeks
interferon-γ (pg/mL) measured at baseline and after 8 weeks
8 weeks
concentration of tumor necrosis factor-α (pg/mL)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
gastrin (pg/mL) measured at baseline and after 8 weeks
8 weeks
concentration of malondialdehyde (mic·mol/L)
Time Frame: 8 weeks
malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks
8 weeks
concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein)
Time Frame: 8 weeks
8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) measured at baseline and after 8 weeks
8 weeks
Nepean dyspepsia index-Korean version (score)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-2020-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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