Study of the Bioavailability of Three Hesperidin Extracts.
キーワード
概要
説明
It will be conducted a post-prandial, randomized, crossover, and double-blind nutritional intervention study.
In a first phase, it will be done a pre-selection process with 30 male and female volunteers over 18 years of age. It will be determined hesperidin excreted levels in urine after the consumption of 500 mL of a homogeneous orange juice among all the participants. Sixteen participants will be selected preferably with an intermediate capacity of hesperidin absorption. The aim of this first phase is to obtain a lower variability in the results in the second phase of the study. Of the sixteen participants, six participants will start the study with the consumption of a hesperidin extract, five with the consumption of the second hesperidin extract and five with the consumption of the third hesperidin extract for, after one week washing period, exchange the hesperidin extracts between the three study groups, and finally repeat the exchange of hesperidin extracts after another week of washing period so that, in the total of the study, each participant had consumed the three hesperidin extracts.
Participants will consume two capsules with 250 mg of extract each, being the total orange extract consumed 500 mg, with 450 mg of hesperidin (90%) and the rest (10%) substances coming from the orange in the process of extracting hesperidin.
During the study there will be 5 visits, one selection (V0), one pre-inclusion (V-1) and 3 study visits (V1, V2 and V3).
日付
| 最終確認済み: | 04/30/2019 |
| 最初に提出された: | 06/06/2019 |
| 提出された推定登録数: | 06/11/2019 |
| 最初の投稿: | 06/12/2019 |
| 最終更新が送信されました: | 06/11/2019 |
| 最終更新日: | 06/12/2019 |
| 実際の研究開始日: | 05/31/2019 |
| 一次完了予定日: | 12/31/2019 |
| 研究完了予定日: | 01/31/2020 |
状態または病気
介入/治療
Dietary Supplement: Hesperidin Pharma
Dietary Supplement: Hesperidin Pharma_M
Dietary Supplement: Cardiose
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Hesperidin Pharma 500 mg of sweet orange extract with a mixture of hesperidin isomers -S and -R. The approximate particle size is less than 100 µm for the 90% of the extract, and of 10 µm for 10% of the extract. | Dietary Supplement: Hesperidin Pharma Two capsules with 250 mg of sweet orange extract with a mixture of hesperidin isomers -S and -R. |
| Active Comparator: Hesperidin Pharma_M 500 mg of sweet orange extract with a mixture of hesperidin isomers -S and -R. The size of 90% of particles is less than 10 µm. | Dietary Supplement: Hesperidin Pharma_M Two capsules with 250 mg of sweet orange extract each with a mixture of hesperidin isomers -S and -R and micronized. |
| Experimental: Cardiose 500 mg of sweet orange extract with more than 90% of the isomer -S. The size of the 90% of particles is less than 10 µm. | Dietary Supplement: Cardiose Two capsules with 250 mg of sweet orange extract each with more than 90% of hesperidin as isomer -S and micronized. |
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: 1. Men and women over 18 years of age. 2. Firm the informed consent. Exclusion Criteria: 1. Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study. 2. Present intolerances and / or food allergies related to hesperidin. 3. Take antibiotics up to 30 days before the start of the study. 4. Being pregnant or intending to become pregnant. 5. Be in breastfeeding period. 6. Be a smoker 7. Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study. 8. Be vegetarian. 9. Present some chronic gastrointestinal disease. 10. Present some chronic disease in clinical manifestation. |
結果
主な結果の測定
1. Bioavailability of hesperidin calculated by urine hesperidin concentration [At week 2, week 3 and week 4.]
二次的な結果の測定
1. Area Under The Curve (AUC) of plasma hesperidin levels. [At week 2, week 3 and week 4.]
2. Maximum plasma concentration (Cmax). [At week 2, week 3 and week 4.]
3. Time for maximum plasma concentration (Tmax). [At week 2, week 3 and week 4.]
4. Half-life (T1/2). [At week 2, week 3 and week 4.]
5. Hesperidin catabolites levels in plasma. [At week 2, week 3 and week 4.]
6. Hesperidin catabolites in urine. [At week 2, week 3 and week 4.]
7. Quantification of hesperidin bioavailability for the selection of individuals [At week 1.]
