Phytochemical Release Rate From Black Raspberry Confections Alters Gene Expression and Chemical Profiles Relevant to Inhibition of Oral Carcinogenesis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Acceptance of candidate formulations, assessed using a 9 point hedonic scale (1 =dislike very much, 9 = like very much)
研究概览
简要总结
This clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. Black raspberry contains ingredients that may prevent or slow the growth of certain cancers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Fast release BRB confection (Other)
Arm II (Fast release BRB confection 8g)
Participants receive two fast release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
干预措施: Fast release BRB confection (Other)
Arm III (Intermed release BRBconfection 4g)
Participants receive one intermediate release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
干预措施: Intermed release BRB confection (Other)
Arm IV (Intermed release BRBconfection 8g)
Participants receive two intermediate release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
干预措施: Intermed release BRB confection (Other)
Arm V (Prolong release BRB confection 4g)
Participants receive one prolonged release BRB confection (4g) PO 4-6 hours apart TID for 2 weeks.
干预措施: Prolong release BRB confection (Other)
Arm VI (Prolong release BRB confection 8g)
Participants receive two prolonged release BRB confection (8g) PO 4-6 hours apart TID for 2 weeks.
干预措施: Prolong release BRB confection (Other)
结局指标
主要结局
Acceptance of candidate formulations, assessed using a 9 point hedonic scale (1 =dislike very much, 9 = like very much)
时间窗: Up to day 14
Compliance and safety of the confections will be evaluated using dietary and sensory questionnaires. The analysis of variance (ANOVA) style model accounting for the random effect of the individual subject and the fixed effect of the dissolution (amorphous confection form) group will be used to examine the effect of attribute data, gender, and age using a 9-point hedonic scale. The significant differences between means of the different groups will be examined using the Ryan-Einot-Gabriel-Welsch (REGW) multiple comparisons test.
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
时间窗: Up to day 14
To select an optimal delivery vehicle \& dose, a combination that results in any of 10 subjects having an adverse event will be eliminated in the 1st stage. In the 2nd and 3rd stages ANOVA style models accounting for the random effect of individual subject and the fixed effect of dose \& release rate will be used to examine phytonutrient metabolite \& gene expression. Using the multiple comparisons with the best procedure, any combination will be eliminated that is significantly worse than the best combination for a global index of bioavailability (stage 2) and gene expression effects (stage 3).
Bioavailability index, defined as the average rank of BRB effect in anthocyanins, ellagic acid, urolithins, and quercetin derivatives
时间窗: Up to day 14
To select an optimal delivery vehicle \& dose, a combination that results in any of 10 subjects having an adverse event will be eliminated in the 1st stage. In the 2nd and 3rd stages ANOVA style models accounting for the random effect of individual subject and the fixed effect of dose \& release rate will be used to examine phytonutrient metabolite \& gene expression. Using the multiple comparisons with the best procedure, any combination will be eliminated that is significantly worse than the best combination for a global index of bioavailability (stage 2) and gene expression effects (stage 3).
次要结局
未报告次要终点
研究者
Yael Vodovotz
Principal Investigator
Ohio State University Comprehensive Cancer Center