NCT04742985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

February 3, 2021

Last Update Submit

July 30, 2021

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • concentration of high-sensitivity C-reactive protein (mg/L)

    8 weeks

  • concentration of interferon-γ (pg/mL)

    8 weeks

  • concentration of tumor necrosis factor-α (pg/mL)

    8 weeks

  • concentration of gastrin (pg/mL)

    8 weeks

  • concentration of malondialdehyde (mic·mol/L)

    8 weeks

  • +4 more secondary outcomes

Study Arms (3)

Green tea combined extracts group A

EXPERIMENTAL

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

Dietary Supplement: Green tea combined extracts group

Green tea combined extracts group B

EXPERIMENTAL

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

Dietary Supplement: Green tea combined extracts group

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 8 weeks.

Dietary Supplement: Placebo group

Interventions

Green tea combined extracts groupDIETARY_SUPPLEMENT

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

Green tea combined extracts group AGreen tea combined extracts group B
Placebo groupDIETARY_SUPPLEMENT

Placebo 320 mg/day during 8 weeks

Placebo group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Study Officials

  • Sang Yeoup Lee, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

February 15, 2021

Primary Completion

June 29, 2021

Study Completion

June 30, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)