Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers
キーワード
概要
説明
PRIMARY OBJECTIVES:
I. To select an optimal black raspberry confection based on altered gene expression and chemical profiles in healthy individuals exposed to 3 black raspberry-based amorphous functional confections with modulated bioactive release rate at two doses (4 g and 8 g).
OUTLINE: Participants are randomized to 1 of 6 arms after 2 weeks.
ARM I: Participants receive black raspberry (BRB) confection 1 fast release orally (PO) 4-6 hours apart thrice daily (TID) for 2 weeks.
ARM II: Participants receive BRB confection 2 fast release PO 4-6 hours apart TID for 2 weeks.
ARM III: Participants receive BRB confection 1 intermediate release PO 4-6 hours apart TID for 2 weeks.
ARM IV: Participants receive BRB confection 2 intermediate release PO 4-6 hours apart TID for 2 weeks.
ARM V: Participants receive BRB confection 1 prolonged release PO 4-6 hours apart TID for 2 weeks.
ARM VI: Participants receive BRB confection 2 prolonged release PO 4-6 hours apart TID for 2 weeks.
日付
| 最終確認済み: | 02/28/2019 |
| 最初に提出された: | 10/09/2013 |
| 提出された推定登録数: | 10/10/2013 |
| 最初の投稿: | 10/13/2013 |
| 最終更新が送信されました: | 03/17/2019 |
| 最終更新日: | 03/18/2019 |
| 実際の研究開始日: | 06/30/2013 |
| 一次完了予定日: | 03/31/2020 |
| 研究完了予定日: | 03/31/2020 |
状態または病気
介入/治療
Other: Fast release BRB confection
Other: Intermed release BRB confection
Other: Prolong release BRB confection
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Arm I (Fast release BRB confection 4g) Participants receive one fast release BRB confection (4g) PO 4-6 hours apart thrice daily (TID) for 2 weeks. | |
| Experimental: Arm II (Fast release BRB confection 8g) Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks. | |
| Experimental: Arm III (Intermed release BRBconfection 4g) Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks. | |
| Experimental: Arm IV (Intermed release BRBconfection 8g) Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks. | |
| Experimental: Arm V (Prolong release BRB confection 4g) Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks. | |
| Experimental: Arm VI (Prolong release BRB confection 8g) Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks. |
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: - Be healthy, free-living adults - Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years) - Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study - Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study - Agree to abstain from mouthwashes Exclusion Criteria: - Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome - Have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias - Have a known allergy or food intolerance to ingredients in study products (black raspberries),other berries, wheat, or soy - Are strict vegans (no consumption of animal, fish or egg products) - Are planning to conceive, or are currently pregnant or lactating - Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/day) - Have a history of oral cancer or currently undergoing treatment of oral cancer - In the last month have had any active oral lesions or maladies or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening - Have strong gag reflex or problems swallowing that prohibit buccal brushing of the oral cavity - Have been on an antibiotic regime lasting for one week in the last 6 months |
結果
主な結果の測定
1. Acceptance of candidate formulations, assessed using a 9 point hedonic scale (1 =dislike very much, 9 = like very much) [Up to day 14]
2. Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives [Up to day 14]
3. Gene expression index, defined as the average rank of BRB effect on expression of genes responsive to BRBs and important to smoking and inflammatory response [Up to day 14]
