A Study Assessing the Tolerable Upper Intake Level and Sa... | NCT05051202

NCT05051202

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: Sugars from Fiber
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	Other: Resistant Maltodextrin
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	Other: Sugars from Fiber
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	Other: Resistant Maltodextrin
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugars from Fiber	Other	Proprietary blend of Sugars from Fiber baked into 50 g flapjack	25g Sugars From Fiber per day 35g Sugars From Fiber per day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	14 days

Secondary Outcomes

Measure	Description	Time Frame
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.	Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass [classified as severe constipation]; Type 7 = watery, entirely liquid stool [classified as severe diarrhea]). 'Normal' stool is considered to be Types 3 and 4; Type 5 would suggest the participant lacks dietary fiber, and Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively. This endpoint will show the incidence of participants experiencing 'diarrhea' Type stool. A lower incidence of diarrhea-type stools would indicate higher fiber content in the groups diet.

Other Outcomes

Measure	Description	Time Frame
Change in fecal Short Chain Fatty Acids (fSCFA) microbiota, in the treatment groups as compared with control, from baseline to Day 14 of intervention		14 days
Change in Faecal pH, in the treatment groups as compared with control, from baseline to Day 14 of intervention

Eligibility Module

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.