Safety and Pharmacokinetics of an Extract of Naringenin
キーワード
概要
説明
Naringenin is a component of food with therapeutic potential to improve glucose metabolism. In order to explore the mechanisms by which naringenin may increase energy expenditure and improve glucose metabolism in humans, it is of vital importance that the safety, tolerability, and bioavailability of naringenin are evaluated, when administered to humans. This study tests the safety of four doses of a citrus extract of naringenin and measures serum concentrations of naringenin at the 150 mg and 600 mg doses over a period of 24 hours, and at the 300 and 900 mg doses at four hours after subjects have been given the respective doses of naringenin.
日付
| 最終確認済み: | 12/31/2019 |
| 最初に提出された: | 06/21/2018 |
| 提出された推定登録数: | 07/08/2018 |
| 最初の投稿: | 07/10/2018 |
| 最終更新が送信されました: | 01/01/2020 |
| 最終更新日: | 01/17/2020 |
| 最初に提出された結果の日付: | 12/01/2019 |
| 最初に提出されたQC結果の日付: | 01/01/2020 |
| 最初に投稿された結果の日付: | 01/17/2020 |
| 実際の研究開始日: | 05/24/2018 |
| 一次完了予定日: | 09/27/2018 |
| 研究完了予定日: | 09/27/2018 |
状態または病気
介入/治療
Dietary Supplement: Naringenin
Other: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: 150 mg dose Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin. | |
| Experimental: 300 mg dose Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin. | |
| Experimental: 600 mg dose Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin. | |
| Experimental: 900 mg dose Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin. | |
| Placebo Comparator: Placebo Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group. | Other: Placebo Cellulose |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Adult (≥18 years) - Body mass index between 20 and 35 kg/m2 - Must have fasting blood sugar <126 mg/dL) - Must be willing to refrain from consuming citrus fruits and tomato in any form, for 36 hours prior to each test day. Exclusion Criteria: - Report citrus allergies. - Report a history of cardiovascular disease, diabetes, or cancer - Have evidence of hepatic disease or dysfunction - Are currently pregnant or breastfeeding - Are women of childbearing potential who will not use an effective method of birth control - Chronically use of medications except over the counter medications that have been stopped 72 hours prior to the study visit - Report clinically significant GI malabsorption syndromes - Have clinically significant abnormal laboratory markers - Anticipate surgery during the study period. - Report history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study. - Have donated blood during the month prior to study entry or plan to do so during the study. - Have participated in other studies using an investigational drug during the preceding three months. - Are current smokers or have smoked within the previous three months. |
結果
主な結果の測定
1. Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin [Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.]
二次的な結果の測定
1. Measurement of Area Under the Serum Naringenin Concentration Versus Time Curve at 150 and 600 mg Doses [0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours]
2. Measurement of Maximal Concentration of Serum Naringenin at 150 and 600 mg Doses [0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours]
3. Measurement of Time to Peak Concentration of Serum Naringenin at 150 and 600 mg Doses [24 hours]
4. Measurement of Half Life of Naringenin at 150 and 600 mg Doses [0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours]
5. Measurement of Apparent Oral Clearance of Naringenin at 150 and 600 mg Doses [0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours]
6. Measurement of Four-hour Concentration of Serum Naringenin at 300 and 900 mg Doses [0 and 4 hours]
