A Blinded, Randomized, Controlled Study to Examine the Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Composite measure of Absorption, Metabolism and Excretion of Phytochemicals
研究概览
简要总结
This is a single site, blinded, randomized, controlled study designed to examine phytochemical absorption, metabolism and excretion, as well as vascular health and satiety, after ingestion of 4 different bean varieties (pinto, navy, red kidney, black). Eligible participants will attend 6 in-person clinic visits for comparative testing of the 4 bean varieties versus lentils and rice.
详细描述
This is a single site, blinded, randomized, controlled study designed to examine phytochemical absorption, metabolism and excretion, as well as vascular health and satiety, after ingestion of 4 different bean varieties (pinto, navy, red kidney, black).
Recruitment will consist of a total of 8 volunteers. Volunteers will be recruited through advertisement from the local community.
The study will be conducted at the I.H. Asper Clinical Research Institute,located at the St. Boniface Hospital. Participants will be asked to provide written informed consent prior to participation in the study. Participants who have provided written consent will be asked to attend an in-patient visit to provide a fasting blood sample. Should the participant be eligible to participate, they will be scheduled for six study visits to assess the bioavailability, metabolism and excretion of phytochemicals present in beans compared to lentils and white rice.
Uptake, metabolism and excretion of phytochemicals present in different varieties of beans during acute phase testing in healthy individuals will be examined. Possible relationships between phytochemical composition of the beans, arterial function and satiety will be investigated as the secondary objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, ≥18 and ≤50 years;
- •Normal blood lipid profile, creatinine ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) ≥0.7 mg/dL and ≤1.3 mg/dL for men and ≥0.6 mg/dL and ≤1.1 mg/dL for women, and glycated hemoglobin <6%;
- •Blood pressure <140/90
- •Body mass index (BMI) ≥20 and <30;
- •Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
- •Agree not to eat beans or bean-based foods, lentils or lentil-based foods, or consume isoflavone supplements while participating in this study;
- •Willing to comply with the protocol requirements;
- •Willing to provide informed consent.
排除标准
- •Allergies to beans, bean flour or bean products, lentils or rice;
- •Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- •Taking any prescribed medication in the last 3 months (with the exception of birth control) or supplements that affect gastrointestinal function in the last 3 months;
- •Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
- •Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
- •Pregnant or lactating;
- •Unable to obtain blood samples at the screening visit or the first study visit.
研究组 & 干预措施
Navy Beans (cooked)
At one of the six visits, participants will consume a ¾ cup of cooked navy beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
干预措施: Navy Beans (cooked) (Other)
Red Kidney Beans (cooked)
At one of the six visits, participants will consume a ¾ cup of cooked red kidney beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
干预措施: Red Kidney Beans (cooked) (Other)
Pinto Beans (cooked)
At one of the six visits, participants will consume a ¾ cup of cooked pinto beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
干预措施: Pinto Beans (cooked (Other)
Black Beans (cooked)
At one of the six visits, participants will consume a ¾ cup of cooked navy beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
干预措施: Black Beans (cooked) (Other)
Lentils (cooked)
At one of the six visits, participants will consume a ¾ cup of cooked lentils. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
干预措施: Lentils (cooked) (Other)
White Rice (cooked)
At one of the six visits, participants will consume a ¾ cup of cooked white rice. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
干预措施: White Rice (Other)
结局指标
主要结局
Composite measure of Absorption, Metabolism and Excretion of Phytochemicals
时间窗: Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption
Blood and urine samples will be analyzed using a differential analysis for metabolites (p\<0.01 and fold changes ≥ 2) which will be achieved via principle component analysis (PCA), and partial least square (PLS).
次要结局
- Satiety Questionnaire(5 hours after consumption of study product)
- Changes in parameters of arterial stiffness through pulse wave analysis (PWA)(Time points 0 (prior to consumption) and 2 and 6 hours post consumption.)
研究者
Dr. Peter Zahradka
Principal Investigator and Professor
University of Manitoba