NCT05051202已完成不适用
A Randomised, Single-blind, Comparator-controlled, Crossover Study, Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber in Healthy Adults
Cambridge Glycoscience1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年6月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in the composite score of gastrointestinal symptoms, (bloating score + abdominal cramping score + stomach noises score + flatulence score), in the treatment groups as compared to control, reported daily in the eDiary
研究概览
简要总结
The purpose of this study is to determine the upper tolerable limit of Sugars from Fiber
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Give written informed consent;
- •Be between 18 and 60 years of age inclusive;
- •Have a body mass index <30 Kg/m2;
- •Be in general good health, as determined by the investigator;
- •Have a habitual dietary intake of ≥13g fibre/day;
- •Self-reported consumption of a generally 'healthy diet'.
排除标准
- •Females who are pregnant, lactating or wish to become pregnant during the study;
- •Participant has self-reported low-energy diet or other extreme dietary habits;
- •Have experienced recurrent loose stool within the past 4 weeks;
- •Recent gastroenteritis or food borne illness such as confirmed food poisoning within the past 4 weeks;
- •Have taken a medication or dietary supplement that may influence GI activity within the 2-weeks prior to screening;
- •Have a history of abdominal surgery (excluding appendectomy);
- •Have taken anaesthesia within the past 4 weeks;
- •Have a known or suspected food allergy or intolerance to any of the investigational product ingredients;
- •Have taken antibiotics within the past 12-weeks;
- •Have a recent history of drug and/or alcohol abuse at the time of enrolment;
- •Are a smoker (defined as >5 cigarettes/week);
- •Have made any major dietary change in the past 3 months;
- •Have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
- •Have an active gastrointestinal disorder or previous gastrointestinal surgery;
- •Have irritable bowel syndrome, diagnosed or undiagnosed and treated with chronic medications;
- •Have a gastrointestinal disease i.e., chronic diarrhoea, Crohn's disease, ulcerative colitis, diverticulosis, stomach or duodenal ulcers, or with a history of such diseases;
- •Have a metabolic or endocrine disorder such as diabetes, thyroidism, or other metabolic disorder;
- •Have a severe chronic disease i.e. cancer, renal failure, hepatitis, HIV, cirrhosis etc., or with a history of such diseases;
- •Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a systemic steroid for >30 days, or chemotherapy or radiotherapy within the last year);
- •Have a personal history of anorexia nervosa, bulimia, or significant eating disorders;
- •Experiences alarm features such as unintentional weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
- •Participants who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
- •Participant is currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
研究组 & 干预措施
25g Sugars From Fiber per day
Experimental
Administered in 50 g Flapjacks containing 25 g Fiber (from Sugars from Fiber), taken 3 times per day, after meals, for a 14 day period
干预措施: Sugars from Fiber (Other)
25g Resistant Maltodextrin per day
Active Comparator
Administered in 50 g Flapjacks containing 25 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period
干预措施: Resistant Maltodextrin (Other)
35g Sugars From Fiber per day
Experimental
Administered in 50 g Flapjack containing 35 g Fiber (from Sugars from Fiber), taken 3 times per day, after meals, for a 14 day period
干预措施: Sugars from Fiber (Other)
35g Resistant Maltodextrin per day
Active Comparator
Administered in 50 g Flapjacks containing 35 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period
干预措施: Resistant Maltodextrin (Other)
45g Sugars From Fiber per day
Experimental
Administered in 50 g Flapjacks containing 45 g Fiber (from Sugars from Fiber), taken 3 times per day, after meals, for a 14 day period
干预措施: Sugars from Fiber (Other)
45g Resistant Maltodextrin per day
Active Comparator
Administered in 50 g Flapjacks containing 45 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period
干预措施: Resistant Maltodextrin (Other)
结局指标
主要结局
Change in the composite score of gastrointestinal symptoms, (bloating score + abdominal cramping score + stomach noises score + flatulence score), in the treatment groups as compared to control, reported daily in the eDiary
时间窗: 14 days
Participants rate each symptom on a 0-5 scale (0 = no symptoms; 5 = severe symptoms). A sum of each of the symptom scores is calculated minimum possible score is 0 and maximum is 30. Higher scores indicate worsening Gastrointestinal symptoms.
次要结局
- Percentage of Participants with worsening GSRS scores between Baseline (Day 0) and Day 14 compared to between Day 21 and Day 35 in the treatments group as compared to control(14 days)
- Absolute change in systolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention(14 days)
- Absolute change in heart rate (BPM) in the treatment groups as compared with control, from baseline to Day 14 of intervention(14 days)
- Incidence of Type 6 (Fluffy pieces with ragged edges - a mushy stool) or Type 7 (Watery, no solid pieces - entirely liquid) Bristol Stool Scale score, in the treatment groups as compared to control, recorded daily in the eDiary.(14 days)
- Difference in mean and highest Bristol Stool Scale score, in the treatment groups as compared to control, reported daily in the eDiary(14 days)
- Absolute change in Gastrointestinal Symptom Rating Scale (GSRS) total score, in the treatment groups as compared to control, from baseline to Day 7 of intervention(14 days)
- Incidence of out of range blood safety parameters (Chemistry and FBC), in the treatment groups as compared to control, from baseline to Day 14 of intervention(14 days)
- Absolute change in GSRS total score, in the treatment groups as compared to control, from baseline to Day 14 of intervention(14 days)
- Difference in severity and frequency of related AEs in the treatment groups as compared to control, reported in the AE Log(14 days)
- Difference in mean stool frequency, in the treatment groups as compared to control, reported daily in the eDiary(14 days)
- Absolute change in diastolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention(14 days)
- Incidence of out of range Urinalysis safety parameters in the treatment groups as compared to control, from baseline to Day 14 of intervention(14 days)
- Absolute change in body temperature (˚C) in the treatment groups as compared with control, from baseline to Day 14 of intervention(14 days)
研究者
研究点 (1)
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