Clinical trial NCT05051202: A Study Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber
Official title: A Randomised, Single-blind, Comparator-controlled, Crossover Study, Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Cambridge Glycoscience
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the upper tolerable limit of Sugars from Fiber


Eligibility criteria: Inclusion Criteria:

* 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'.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: 14 days
Secondary outcomes:
measure: 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.
timeFrame: 14 days
measure: Difference in mean and highest Bristol Stool Scale score, in the treatment groups as compared to control, reported daily in the eDiary
timeFrame: 14 days
measure: Difference in mean stool frequency, in the treatment groups as compared to control, reported daily in the eDiary
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: Absolute change in GSRS total score, in the treatment groups as compared to control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: Difference in severity and frequency of related AEs in the treatment groups as compared to control, reported in the AE Log
timeFrame: 14 days
measure: 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
timeFrame: 14 days
measure: Incidence of out of range Urinalysis safety parameters in the treatment groups as compared to control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: Absolute change in systolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: Absolute change in diastolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: Absolute change in heart rate (BPM) in the treatment groups as compared with control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: Absolute change in body temperature (˚C) in the treatment groups as compared with control, from baseline to Day 14 of intervention
timeFrame: 14 days
Other outcomes:
measure: Change in fecal Short Chain Fatty Acids (fSCFA) microbiota, in the treatment groups as compared with control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: Change in Faecal pH, in the treatment groups as compared with control, from baseline to Day 14 of intervention
timeFrame: 14 days
measure: Change in microbial community analysed using Shallow Shotgun Sequencing, in the treatment groups as compared with control, from baseline to Day 14 on intervention
timeFrame: 14 days
measure: Detection of oligosaccharides in plasma at Day 14 on intervention.
timeFrame: 14 days
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
affiliation: Atlantia Food Clinical Trials
name: Timothy Dinan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: