Evaluation of Safety and Tolerability of a Rapeseed Food Ingredient Among Generally Healthy Consumers - A Randomized Double-blind, Controlled Parallel-group Four-week Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in digestive symptom frequency score
研究概览
简要总结
The study is designed to assess the safety and tolerability of a novel food ingredient produced from rape seeds supplied as a snack-bar in a 4-week controlled intervention.
详细描述
An 4-week randomized, double-blind, controlled, parallel-group intervention for assessment of safety and tolerability of a novel rape seed ingredient (RI) followed by a 2-week follow-up period. Baseline measures for digestive symptom frequency questionnaire (DSFQ), blood safety tests and body mass index (BMI) will be collected at screening visit. At the randomization visit, participants' eligibility will be confirmed, and they will be randomly allocated into 2 parallel groups consuming either 20 g (test group) or 0 g (control group) of RI within 2 daily snack bars. During the intervention and follow-up periods participants will bi-weekly respond to a GI symptom questionnaire including DSFQ, stool frequency and stool consistency, and palatability items. At the end of the intervention period (week 4) a clinic visit including BMI and AE recording and blood safety tests will be held.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Age 18-75 years (inclusive)
- •Body mass index (BMI) 18.5 - 30 (inclusive)
- •Good general health according to medical history and current health status
排除标准
- •Allergy or sensitivity to any ingredient of the study products
- •Nut or mustard allergy
- •Any major diseases or malfunctions including i. Inflammatory bowel disease or functional bowel disorder or any major gastrointestinal medical condition ii. type 1 or 2 diabetes requiring medication iii. active hepatic, kidney or thyroid disease or disorder except if subject on thyroid replacement therapy iv. myocardial infarction, unstable symptomatic angina pectoris, or transient ischemic attack or stroke within 3 months prior to screening v. cancer or cancer treatment within 5 years prior to screening (not including basal cell carcinoma)
- •Medication used for treatment of elevated blood glucose levels
- •Pregnancy, lactation or planned pregnancy during the trial
- •Clinically significant abnormalities in safety laboratory values according to the investigator
- •Strict low-carbohydrate or low-fat diet
- •Participation in another clinical trial in the preceding 1 month
- •Likelihood of any health or safety risk according to the Investigator
- •Likelihood of non-compliance according to the Investigator
研究组 & 干预措施
Test group
20 g of rapeseed ingredient (RI) daily
干预措施: Rapeseed ingredient (RI) (Other)
Control group
0 g of rapeseed ingredient (RI) daily
干预措施: Control product without added RI (Other)
结局指标
主要结局
Change in digestive symptom frequency score
时间窗: Change from week 0 to week 4
Change in composite frequency score of four gastrointestinal (GI) symptoms according to the digestive symptom frequency questionnaire (DSFQ; combined score for four questions ranging from 0 to 16; subjective evaluation)
次要结局
- Number of adverse events(0-6 weeks)
- Change in stool consistency(Change from week 0 to week 4)
- Change in clinical significance status of screening blood safety tests(Change from week -2 to week 4)
- Palatability(2-4 weeks)
- Change in defecation frequency(Change from week 0 to week 4)
- Change in body mass index (BMI)(Change from week -2 to week 4)