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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green tea combined extracts group A | Experimental | This group takes Green tea combined extracts (62.5 mg) for 8 weeks. |
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| Green tea combined extracts group B | Experimental | This group takes Green tea combined extracts (125 mg) for 8 weeks. |
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| Placebo group | Placebo Comparator | This group takes placebo for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea combined extracts group | Dietary Supplement | Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| concentration of interferon-γ (pg/mL) | interferon-γ (pg/mL) measured at baseline and after 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| Placebo group | Dietary Supplement | Placebo 320 mg/day during 8 weeks |
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| 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 | 8 weeks |
| concentration of gastrin (pg/mL) | gastrin (pg/mL) measured at baseline and after 8 weeks | 8 weeks |
| concentration of malondialdehyde (mic·mol/L) | malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks | 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 | 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. | 8 weeks |
| 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 |
| 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 |