Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone.
研究概览
简要总结
This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG.
It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults: 18-45 and 60-80 years of age
排除标准
- •Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
- •Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
- •Individuals who smoke
- •Individuals who have experienced diarrhea in the last three months
- •Individuals who have taken oral antibiotics in the last three months
- •Individuals who are currently taking warfarin or any of its derivatives
- •Individuals with low haemoglobin (<121g/L for women and <137g/L for men)
- •Individuals with BMI under 19 or over 28
- •Pregnant or lactating women
- •Women with child bearing potential not using contraceptives
- •Current diagnosis of a bleeding disorder or at risk of bleeding
- •Individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
- •Individuals with diabetes mellitus
- •Individuals currently taking a flax seed supplement
- •Individuals with an allergy to flax seed
- •Individuals who have donated blood or lost > 450 mL of blood within 56 days of study duration
- •Individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial
结局指标
主要结局
Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone.
时间窗: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone.
时间窗: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Terminal phase half-life of secoisolariciresinol, enterodiol and enterolactone.
时间窗: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Area under the plasma concentration versus time curve (AUC) of secoisolariciresinol, enterodiol and enterolactone.
时间窗: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
Elimination rate constant (k) of secoisolariciresinol, enterodiol and enterolactone.
时间窗: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.
次要结局
- Inflammatory markers(at 0 hours - prior to study commencement)
- Activity questionnaire(at 0 hours - prior to study commencement)
- Food frequency questionnaire(at 0 hours - prior to study commencement)
研究者
Jane Alcorn
Ph.D.
University of Saskatchewan