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

NCT05051202 | Completed

• 1 other identifier: CG1141
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• 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 (13)

• 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

• Difference in mean stool frequency, 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

• Absolute change in GSRS total score, in the treatment groups as compared to control, from baseline to Day 14 of intervention

  14 days

Other Outcomes (4)

• 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

  14 days

• Change in microbial community analysed using Shallow Shotgun Sequencing, in the treatment groups as compared with control, from baseline to Day 14 on intervention

  14 days

Study Arms (6)

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

Other: Sugars from Fiber

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

Other: Resistant Maltodextrin

Interventions

Sugars from Fiber OTHER

Proprietary blend of Sugars from Fiber baked into 50 g flapjack

Also known as: SFF

25g Sugars From Fiber per day; 35g Sugars From Fiber per day; 45g Sugars From Fiber per day

Resistant Maltodextrin OTHER

Resistant Maltodextrin baked into 50 g flapjack

Also known as: RM

25g Resistant Maltodextrin per day; 35g Resistant Maltodextrin per day; 45g Resistant Maltodextrin per day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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'.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cambridge Glycoscience: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

Related Publications (1)

• 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.

  PMID: 38032277 DERIVED

Study Officials

• Timothy Dinan, Ph.D

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: September 21, 2021
• Study Start: June 21, 2021
• Primary Completion: January 29, 2022
• Study Completion: January 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)