Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
研究概览
简要总结
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at different doses)
详细描述
The study will have a randomized, double-blind, crossover design with 5 visits consisting of one screening visit and 5 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 4 test products made with the sugar replacer ingredients or blend of ingredients over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and ~1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (abdominal bloating, abdominal pain, flatulence, burping, reflux (heartburn), stomach rumbling (borborygmus), nausea and vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated 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 so study staff and research participants will be blinded as to which test meal is which. After the database will be cleaned and locked, and statistical analysis will be completed, and 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
结局指标
主要结局
Total Area Under the Curve (tAUC) of composite gastrointestinal Symptom score
时间窗: tAUC between 0 and 24 hours
total area under the curve (tAUC) of the composite GastroIntestinal symptom score (sum of the scores for the 8 GI symptoms). The score values can range from 0 up to 24 with the higher values showing the higher levels of symptoms (worse conditions).
次要结局
- Frequency of Diarrhea within 24 hours(Evaluation performed over 24 hour after consumption of study products)
- Time for maximum score for reflux(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Time for maximum score for abdominal bloating(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Time of maximum score for abdominal pain(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Time for maximum score for vomiting(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- incomplete evacuation(Evaluation performed over 24 hour after consumption of study products)
- Stool consistency based on bristol stool scale(Evaluation performed over 24 hour after consumption of study products)
- Total Area Under the Curve of each individual gastrointestinal symptom(tAUC between 0 and 24 hours)
- Time for maximum score for flatulence(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Frequency of composite score > 1 at each time point(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Time for maximum score for burping(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Number of bowel movements(Evaluation performed over 24 hour after consumption of study products)
- discomfort during bowel movement(Evaluation performed over 24 hour after consumption of study products)
- Time for maximum score for stomach rumbling(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Time for maximum score for nausea(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- straining during bowel movement(Evaluation performed over 24 hour after consumption of study products)
- Maximum score for stomach rumbling(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for nausea(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for vomiting(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for abdominal bloating(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for abdominal pain(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for flatulence(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for burping(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)
- Maximum score for reflux(Evaluation performed at time 0, 2, 4, 6, 10 and 24 hours)