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

NCT ID: NCT05051202

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2022-01-30

Brief Summary

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

Conditions

Gastrointestinal Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

25g Sugars From Fiber per day

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

Group Type: EXPERIMENTAL

Sugars from Fiber

Intervention Type: OTHER

Proprietary blend of Sugars from Fiber baked into 50 g flapjack

25g Resistant Maltodextrin per day

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

Group Type: ACTIVE_COMPARATOR

Resistant Maltodextrin

Intervention Type: OTHER

Resistant Maltodextrin baked into 50 g flapjack

35g Sugars From Fiber per day

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

Group Type: EXPERIMENTAL

Sugars from Fiber

Intervention Type: OTHER

Proprietary blend of Sugars from Fiber baked into 50 g flapjack

35g Resistant Maltodextrin per day

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

Group Type: ACTIVE_COMPARATOR

Resistant Maltodextrin

Intervention Type: OTHER

Resistant Maltodextrin baked into 50 g flapjack

45g Sugars From Fiber per day

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

Group Type: EXPERIMENTAL

Sugars from Fiber

Intervention Type: OTHER

Proprietary blend of Sugars from Fiber baked into 50 g flapjack

45g Resistant Maltodextrin per day

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

Group Type: ACTIVE_COMPARATOR

Resistant Maltodextrin

Intervention Type: OTHER

Resistant Maltodextrin baked into 50 g flapjack

Interventions

Sugars from Fiber

Proprietary blend of Sugars from Fiber baked into 50 g flapjack

Intervention Type: OTHER

Resistant Maltodextrin

Resistant Maltodextrin baked into 50 g flapjack

Intervention Type: OTHER

Other Intervention Names

SFF; RM

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cambridge Glycoscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Dinan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Atlantia Food Clinical Trials

Locations

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

Ireland

References

Moura de Oliveira Beltrame D, Simmons TJ, Jenkins AL, Dinan T, Nicholson TJ. Gastrointestinal Tolerability and Acute Glycemic Response of Oligosaccharides and Polysaccharides from Cellulose and Xylan in Healthy Adults: Two Double-Blinded, Randomized, Controlled, Cross-over Trials. J Am Nutr Assoc. 2024 May-Jun;43(4):305-314. doi: 10.1080/27697061.2023.2282615. Epub 2023 Nov 30.

Reference Type: DERIVED

PMID: 38032277 (View on PubMed)

Other Identifiers

CG1141

Identifier Type: -

Identifier Source: org_study_id