Gastrointestinal ToleranceNCT05051202
A Study Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber
A study testing Sugars from Fiber and Resistant Maltodextrin in people with Gastrointestinal Tolerance, run by Cambridge Glycoscience at 1 site in Ireland.
Trial summary
The purpose of this study is to determine the upper tolerable limit of Sugars from Fiber Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Sugars from Fiber and Resistant Maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteIreland
- Study dates
- 21 Jun 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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'.
Who cannot join
- 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);
Show all 23Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to determine the upper tolerable limit of Sugars from Fiber
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Sugars from Fiber, Resistant Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugars from FiberOther
Also called SFF
Proprietary blend of Sugars from Fiber baked into 50 g flapjack
Resistant MaltodextrinOther
Also called RM
Resistant Maltodextrin baked into 50 g flapjack
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Resistant Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 14 days
Difference in mean and highest Bristol Stool Scale score, in the treatment groups as compared to control, reported 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. Lower 'types' are indicative of constipation, and higher 'types' are indicative of diarrhea.
Measured: 14 days
Difference in mean stool frequency, in the treatment groups as compared to control, reported 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. Lower 'types' are indicative of constipation, and higher 'types' are indicative of diarrhea.
Measured: 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
The Gastrointestinal Symptom Rating Scale questionnaire contains 15 items, each uses a seven-graded Likert scale, where 1 represents the most positive option (no symptoms) and 7 the most negative one (severe symptoms). The participant will answer each question with respect to their experience over the last 7 days. To calculate the Total Score, each of the 15 item scores will be used to calculate a mean Total Score: minimum possible score = 0; maximum possible score = 7; higher scores indicate worse symptoms.
As the recall period is 7 days, the Baseline value will give a score from Day -6 to Day 0, and the Day 7 value will give a score from Day 1 to Day 7 - a 14 day period overall.
Measured: 14 days
Absolute change in GSRS total score, in the treatment groups as compared to control, from baseline to Day 14 of intervention
The Gastrointestinal Symptom Rating Scale questionnaire contains 15 items, each uses a seven-graded Likert scale, where 1 represents the most positive option (no symptoms) and 7 the most negative one (severe symptoms). The participant will answer each question with respect to their experience over the last 7 days. To calculate the Total Score, each of the 15 item scores will be used to calculate a mean Total Score: minimum possible score = 0; maximum possible score = 7; higher scores indicate worse symptoms.
As the recall period is 7 days, the Baseline value will give a score from Day -6 to Day 0, and the Day 7 value will give a score from Day 1 to Day 7 - a 14 day period overall.
Measured: 14 days
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
The Gastrointestinal Symptom Rating Scale questionnaire contains 15 items, each uses a seven-graded Likert scale, where 1 represents the most positive option (no symptoms) and 7 the most negative one (severe symptoms). The participant will answer each question with respect to their experience over the last 7 days. To calculate the Total Score, each of the 15 item scores will be used to calculate a mean Total Score: minimum possible score = 0; maximum possible score = 7; higher scores indicate worse symptoms.
As the recall period is 7 days, the Baseline value will give a score from Day -6 to Day 0, and the Day 7 value will give a score from Day 1 to Day 7 - a 14 day period overall.
Measured: 14 days
Difference in severity and frequency of related AEs in the treatment groups as compared to control, reported in the AE Log
Measured: 14 days
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
This outcome will report the incidence of 'out of range' blood safety parameters assessed from a standard safety chemistry panel (ALT, AST, BUN, Chloride, Creatinine, Potassium, Protein, Sodium) and a standard safety hematology panel (WBC, RBC, Hemoglobin, Hematocrit, Platelets, MCV, MCH, MCHC, RDW). 'Out of range' is determined based on clinically defined 'normal' ranges for each analyte. A higher incidence of 'out of range' blood safety parameters would be a worse safety outcome in this case.
Measured: 14 days
Incidence of out of range Urinalysis safety parameters in the treatment groups as compared to control, from baseline to Day 14 of intervention
This outcome will report the incidence of 'out of range' Urinalysis safety parameters (Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte Esterase). 'Out of range' is determined based on clinically defined 'normal' ranges for each analyte. A higher incidence of 'out of range' urinalysis safety parameters would be a worse safety outcome in this case.
Measured: 14 days
Absolute change in systolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Measured: 14 days
Absolute change in diastolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Measured: 14 days
Absolute change in heart rate (BPM) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Measured: 14 days
Absolute change in body temperature (˚C) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start21 Jun 2021
- Primary completion29 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Glycoscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Ph.D, Principal investigator, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051202
- Sponsor's protocol ID
- CG1141
- Status last verified
- Oct 2022
- First submitted
- 14 Jun 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38032277
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05051202
- Acronym / sponsor ID
- CG1141
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Cambridge GlycoscienceIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the upper tolerable limit of Sugars from Fiber
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 25g Sugars From Fiber per day | Experimental | Other: Sugars from FiberAdministered in 50 g Flapjacks containing 25 g Fiber (from Sugars from Fiber), taken 3 times per day, after meals, for a 14 day period |
| 25g Resistant Maltodextrin per day | Active comparator | Other: Resistant MaltodextrinAdministered in 50 g Flapjacks containing 25 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period |
| 35g Sugars From Fiber per day | Experimental | Other: Sugars from FiberAdministered in 50 g Flapjack containing 35 g Fiber (from Sugars from Fiber), taken 3 times per day, after meals, for a 14 day period |
| 35g Resistant Maltodextrin per day | Active comparator | Other: Resistant MaltodextrinAdministered in 50 g Flapjacks containing 35 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period |
| 45g Sugars From Fiber per day | Experimental | Other: Sugars from FiberAdministered in 50 g Flapjacks containing 45 g Fiber (from Sugars from Fiber), taken 3 times per day, after meals, for a 14 day period |
| 45g Resistant Maltodextrin per day | Active comparator | Other: Resistant MaltodextrinAdministered in 50 g Flapjacks containing 45 g Resistant Maltodextrin, taken 3 times per day, after meals, for a 14 day period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugars from FiberAlso: SFFProprietary blend of Sugars from Fiber baked into 50 g flapjack | Other | 25g Sugars From Fiber per day, 35g Sugars From Fiber per day, 45g Sugars From Fiber per day |
| Resistant MaltodextrinAlso: RMResistant Maltodextrin baked into 50 g flapjack | Other | 25g Resistant Maltodextrin per day, 35g Resistant Maltodextrin per day, 45g Resistant Maltodextrin per day |
Primary outcome
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
Time frame: 14 days
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.
13 secondary outcomes
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.
Time frame: 14 days
Difference in mean and highest Bristol Stool Scale score, in the treatment groups as compared to control, reported daily in the eDiary
Time frame: 14 days
Difference in mean stool frequency, in the treatment groups as compared to control, reported daily in the eDiary
Time frame: 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
Time frame: 14 days
Absolute change in GSRS total score, in the treatment groups as compared to control, from baseline to Day 14 of intervention
Time frame: 14 days
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
Time frame: 14 days
Difference in severity and frequency of related AEs in the treatment groups as compared to control, reported in the AE Log
Time frame: 14 days
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
Time frame: 14 days
Incidence of out of range Urinalysis safety parameters in the treatment groups as compared to control, from baseline to Day 14 of intervention
Time frame: 14 days
Absolute change in systolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Time frame: 14 days
Absolute change in diastolic blood pressure (mmHg) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Time frame: 14 days
Absolute change in heart rate (BPM) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Time frame: 14 days
Absolute change in body temperature (˚C) in the treatment groups as compared with control, from baseline to Day 14 of intervention
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 38032277Moura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dinan, Ph.D principal investigator
Atlantia Food Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugars from Fiber and Resistant Maltodextrin in people with Gastrointestinal Tolerance, run by Cambridge Glycoscience at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.