Evaluating the Impact of Fat and Sugar Replacer Blends on Gastrointestinal Tolerance in Biscuits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
研究概览
简要总结
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance and bowel habits of sugar- and fat- replacer ingredients and blends (maltitol, polydextrose, allulose and EPG)
详细描述
The study will have a randomized, double-blind, crossover design with 8 visits consisting of one screening visit and 7 study visits (3 to 14-day interval between the start of each visit) across 4-12 weeks. Participants will be randomized to a test sequence and, during the course of the study, will complete 7 trial arms. At each visit eligible participants will come to INQUIS between 8-11am, and ~1-2h after consuming their usual breakfast at home. After rating the severity of GI symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 11 symptoms will be rated at 0, 2, 4, 6, 10 and 24h: Abdominal bloating, Abdominal pain, Gas/flatulence, Gas with discharge, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Urgency of bowel movement, Oily spotting (leakage), Nausea and Vomiting. The severity of each symptom will be rated by the subject as None, Mild, Moderate or Severe (these ratings will be assigned scores of 0, 1, 2 or 3, respectively). For each bowel movement (BM) passed during the 24h period, participants will be asked to record: the time, if they had to strain (yes or no), if they experienced discomfort (yes or no), if they felt there was incomplete evacuation (yes or no), if they had oily evacuation (oil separated from the stools) (yes or no), if they had oily stool (oily lumps in the stool) (yes or no) and the consistency of the stool rated using the using the Bristol Stool Scale (BSS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The products will be labelled with a code, and participants will not be informed which test meal is which. Double blinding will be achieved by identifying the treatments by code on the case report forms and, in the database, so that those doing the statistical analysis and the study sponsor will be unaware of the treatment assignments. After the database has been created, cleaned, and locked a copy will be sent to the sponsor and then the codes will be broken.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-pregnant, non-lactating, healthy individuals aged 18-55 years, inclusive
- •Body Mass Index (BMI) 18.5-32.0kg/m², inclusive
- •No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
- •Ability to understand the study procedures and willing to provide informed consent to participate in the study
- •Non-smokers or smokers who smoke <10 cigarettes/day and are willing not to change nicotine habits during the study period
- •Willing to limit alcohol consumption to ≤3 standard drinks/day and ≤7 standard drinks/week during the study period
- •Willing to refrain from any marijuana or hemp products during the study period
- •Normal bowel habits (>2 bowel movements/week and <3 bowel movements per day)
- •Consumes ≤4 servings/day of fruits and vegetables combined and ≤3 (women) or ≤4 (men) servings/day of whole grains using the definitions of "serving" .
- •Participants must have a cell phone/tablet/computer and be willing and able to use it to collect study data
- •Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP (Ontario Health Insurance Plan)
- •Participants are willing to follow current COVID guidelines with respect to attending study visits
排除标准
- •Failure to meet any one of the inclusion criteria
- •Chronic moderate to severe gastrointestinal symptoms
- •Use of systemic antibiotics, antifungals or antiparasitics in the past 3 months and during the experimental period
- •Use of medications, supplements, and products which may affect the results (laxative, anti-diarrhea, anti-constipation drugs, high fiber supplements)
- •Individuals with any medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal - Investigator
- •Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- •Known intolerance, sensitivity, or allergy to any ingredients in the study test products
- •Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification