2019 Fiscal Year Research-status Report
Evaluation of Potential Role of Olive Leaf Extract as A Natural Way to Prevent and Improve Anemia: A randomized Clinical Trial in Japan and Tunisia
| Project/Area Number |
19K20106
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| Research Institution | University of Tsukuba |
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Principal Investigator |
FERDOUSI FARHANA 筑波大学, 地中海・北アフリカ研究センター, 研究員 (80820927)
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| Project Period (FY) |
2019-04-01 – 2022-03-31
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| Keywords | Olive leaf extract / anemia / hematological parameter |
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| Outline of Annual Research Achievements |
1. Ethical approval was received to perform the clinical trial in International Centre for Diarrhoeal Disease Research, Bangladesh.
研究課題名:乾燥オリーブ葉茶の継続摂取が貧血関連パラメーターの変化に及ぼす影響の検討-バングラデシュにおけるランダム化3群並行群間比較試験- (Ethics Committee: University of Tsukuba Hospital Ethics Committee).
2. A small-scale pilot study has been performed to evaluate efficacy, safety, and feasibility of the Olive Leaf Extract (OLE) in eight Female Study Participants in Japan. Results showed that (A) Red blood cell (RBC) count was significantly increased after 6- and 8- week of OLE capsule intake, (B) Although not statistically significant, hemoglobin count was also increased after 6- and 8- week of OLE capsule intake,(C) Serum Fe, Serum Ferritin, and Hematocrit showed a sharp decrease after 6 weeks of OLE intervention (non-significant). It indicates rapid RBC production, which leads plasma iron turnover (PIT) and a decrease in the half-time of iron in the plasma. We will further evaluate Serum Erythropoietin levels in our next clinical trial to confirm this mechanism of action, (D) OLE did not show any hepatic and renal toxicity during the 8-week intervention.
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| Current Status of Research Progress |
Current Status of Research Progress
3: Progress in research has been slightly delayed.
Reason
We have already obtained ethical clearance from the University to perform the clinical trial. A small-scale study in eight female volunteers showed that our proposed olive extract improves red blood cell count. However, we could not start our large scale clinical trial in Bangladesh due to the COVID-19 pandemic situation.
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| Strategy for Future Research Activity |
For the second fiscal year, we will conduct the proposed clinical trial in Bangladesh in 300 study participants, including both male and female, aged between 15-60 years of old. Now, we have all the olive extract capsule of two different doses and the placebo capsules prepared.There was budget confirmation from the study site in Bangladesh. We will proceed to research agreement between University of Tsukuba and icddr,b (Bangladesh). We can start our clinical trial as soon as COVID 19 situation gets better in Bangladesh. Because of corona situation, I had to cancel study site (Bangladesh) visit scheduled in March, 2020.
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| Causes of Carryover |
In the first fiscal year, we did not start the clinical study. Therefore, we have remaining of the budget. Moreover, I had to cancel research study site (Bangladesh) visit in March, 2019 because of COVID 19 pandemic situation. In the second fiscal year, we are planning to start the clinical study, therefore, we will need the most of the budget in this year. At the end of the year, we may require field visit, and domestic conference attend.
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