A Study Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber

Cambridge Glycoscience

Status: Completed

Conditions: Gastrointestinal Tolerance

Treatments: Other: Sugars from Fiber; Other: Resistant Maltodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051202

CG1141

Details and patient eligibility

About

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 6 patient groups

25g Sugars From Fiber per day

Experimental group

Description:

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

Treatment:

Other: Sugars from Fiber

25g Resistant Maltodextrin per day

Active Comparator group

Description:

Administered in 50 g Flapjacks containing 25 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period

Treatment:

Other: Resistant Maltodextrin

35g Sugars From Fiber per day

Experimental group

Description:

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

Treatment:

Other: Sugars from Fiber

35g Resistant Maltodextrin per day

Active Comparator group

Description:

Administered in 50 g Flapjacks containing 35 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period

Treatment:

Other: Resistant Maltodextrin

45g Sugars From Fiber per day

Experimental group

Description:

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

Treatment:

Other: Sugars from Fiber

45g Resistant Maltodextrin per day

Active Comparator group

Description:

Administered in 50 g Flapjacks containing 45 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period

Treatment:

Other: Resistant Maltodextrin