Signs and Symptoms, DigestiveNCT02532985
Gastrointestinal Tolerability Following Multiple Servings of a Novel Dietary Fiber
A study testing Novel Fiber in people with Signs and Symptoms, Digestive, run by Cargill.
Trial summary
The study will assess the gastrointestinal tolerability of multiple servings of a novel dietary fiber at three different dose levels in generally healthy men and women. Double-blind controlled, cross-over clinical trial with negative (no added fiber) and positive controls. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Digestive
- What is being tested?
- Novel Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2015
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female, 18-54 years of age, inclusive.
- Subject has body mass index (BMI) ≥18.50 and ≤39.99 kg/m2 at visit 1 (day -7) and has been weight stable (± 4.5 kg) for the previous 3 months.
- Subject is judged to be in good health on the basis of medical history.
- Subject is willing to maintain his or her habitual diet and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period.
- Subject is willing to avoid foods/beverages that cause GI-distress, as well as high-fiber foods for 24 h prior to test visits.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.
Who cannot join
- Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance).
- History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Recent history (within 6 weeks of screening, visit 1) of constipation (defined as <3 bowel movements per week), and/or diarrhea (defined as ≥3 loose or liquid stools/d).
- Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea.
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS),
- Daily use of antacids, proton pump inhibitors, and/or H2 blockers.
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- Recent use of antibiotics (within 3 months of visit 2, day 0).
- Use of medications (over-the-counter and prescription) or dietary supplements (within 3 weeks of visit 2, day 0) known to influence GI function such as constipation medications and supplements (including laxatives, enemas, fiber supplements and/or suppositories); anti-diarrheal agents; anti-spasmodic; prebiotic and probiotic supplements.
- Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet.
- Known allergy or sensitivity to food ingredients such as: soy, dairy (milk), wheat, egg, peanuts, tree nuts, fin fish and crustacean.
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at visit 1, day -7).
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Any major trauma or surgical event within 2 months of visit 2, day 0.
- Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who were unwilling to commit to use of a medically approved form of contraception throughout the study period.
- Exposure to any non-registered drug product within 30 days previous to the screening visit.
- Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Recent history of (within 2 months of visit 1) use of any tobacco-containing products.
About this study
Official title: A Randomized, Double-Blind, Crossover Study to Assess Gastrointestinal Tolerability of Cba-1, a Novel Dietary Fiber, Using Three Dose Levels at Multiple Eating Occasions in Healthy Men and Women
The study will assess the gastrointestinal tolerability of multiple servings of a novel dietary fiber at three different dose levels in generally healthy men and women. Double-blind controlled, cross-over clinical trial with negative (no added fiber) and positive controls. Multiple servings over 24h, with data collection at 24 and 48h and 1 week wash-out between cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to 18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control will be delivered in 240 ml beverages.
Read the detailed description
This is a randomized, double-blind, five test periods crossover study consisting of a screening visit (visit 1, day -7) and 10 test visits (days 0, 2, 7, 9, 14, 16, 21, 23, 28, 30). At the screening visit, after subjects have provided informed consent, medical history and clinic visit procedures will be performed. Subjects who meet the study criteria will be instructed to maintain habitual diet and physical activity patterns throughout the study period. Subjects will also be instructed to avoid foods/ beverages that cause Gastrointestinal (GI)-distress, as well as high-fiber foods for the 24 h prior to and throughout each 48 h test period. Additional instructions will include avoiding the use of non-steroidal anti-inflammatory drugs (NSAIDS), antacids, proton pump inhibitors (PPIs), and H2 receptor antagonists for the 48 h prior to the next clinic visit (visit 2, day 0). At the test visits, eligible subjects will undergo clinic visit procedures, including assessment of adverse events (AEs).
At the beginning of each test period (Visits 2, 4, 6, 8, and 10), subjects will arrive at the clinic after a 9-14 h fast and will be administered one serving of their assigned study product to consume within 15 min with a standard breakfast meal (t = 0 h). Subjects will remain in the clinic and will be provided a second serving of their assigned study product to consume within 15 min with a standard lunch meal at t= 4 ± 0.5 h. Subjects will then be provided the third and fourth servings of their assigned study product and instructed to consume the study product in its entirety within 15 min of their also provided afternoon snack, and evening dinner, respectively, and to allow at least 3 h between eating occasions. Compliance with dispensed product and meal consumption will be confirmed with a diet record. Subjects will be also instructed to complete a GI Tolerability Questionnaire the next morning (t=24h) after an overnight fast (9-14h). A Bowel Habits Diary will be completed from the initial study product consumption (t= 0) until the subsequent clinic visit (t= 48 h). Subjects will return to the clinic at t= 48 h (Visits 3, 5, 7, 9, and 11) after an overnight fast (9-14 h) to complete the test period, at which time a 48 h GI Tolerability Questionnaire will also be completed.
A washout period of 7 d will occur between each test period (e.g., before Visits 4, 6, 8, and 10), after which subjects will return to the clinic to cross over to the next study product in their test sequence.
- Conditions
- Signs and Symptoms, Digestive
- Being tested
- Negative Control, Positive Fiber Control, Novel Fiber
- Keywords
- Gastrointestinal tolerability, dietary fiber, clinical trial, healthy subjects
- Medical subject headings
- Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative ControlOther
No added fiber beverage
Positive Fiber ControlOther
Also called Polydextrose
positive control fiber supplemented beverage provided over 4 servings
Novel FiberOther
Also called Cba-1
novel fiber supplemented beverage provided over 4 servings
Novel FiberOther
Also called Cba-1
novel fiber supplemented beverage provided over 4 servings
Novel FiberOther
Also called Cba-1
novel fiber supplemented beverage provided over 4 servings
| Study group | Role | What they receive |
|---|---|---|
| Negative control | Placebo comparator | No added fiber Receives: Other: Negative Control |
| Positive fiber control | Active comparator | 90g positive control fiber Receives: Other: Positive Fiber Control |
| Novel fiber 30g | Experimental | 30g novel fiber Receives: Other: Novel Fiber |
| Novel fiber 60g | Experimental | 60g novel fiber Receives: Other: Novel Fiber |
| Novel fiber 90g | Experimental | 90g novel fiber Receives: Other: Novel Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Gastrointestinal GI Symptom Score among conditions
Composite score will be calculated for each intake level as the sum of the ratings of the individual components (abdominal distention/bloating, gas/flatulence, borborygmus/stomach rumbling, and abdominal cramping). The ratings will be coded using a 4-point scale, in which 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
Measured: 24 hours
Composite Gastrointestinal GI Symptom Score among conditions
Composite score will be calculated for each intake level as the sum of the ratings of the individual components (abdominal distention/bloating, gas/flatulence, borborygmus/stomach rumbling, and abdominal cramping). The ratings will be coded using a 4-point scale, in which 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, DigestiveStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532985
- Sponsor's protocol ID
- BIO-1411
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover Study to Assess Gastrointestinal Tolerability of Cba-1, a Novel Dietary Fiber, Using Three Dose Levels at Multiple Eating Occasions in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT02532985
- Acronym / sponsor ID
- BIO-1411
- Conditions
- Signs and Symptoms, Digestive
- Keywords
- Gastrointestinal tolerability, dietary fiber, clinical trial, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Aug 2015 (estimated)
- 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 study will assess the gastrointestinal tolerability of multiple servings of a novel dietary fiber at three different dose levels in generally healthy men and women. Double-blind controlled, cross-over clinical trial with negative (no added fiber) and positive controls. Multiple servings over 24h, with data collection at 24 and 48h and 1 week wash-out between cross-overs. 45 randomized, generally healthy men and women, 18-54 y, BMI higher or equal to 18.5 and smaller or equal to 39.99 kg/m2. Novel dietary fiber ingredient and positive control will be delivered in 240 ml beverages.
Detailed description
This is a randomized, double-blind, five test periods crossover study consisting of a screening visit (visit 1, day -7) and 10 test visits (days 0, 2, 7, 9, 14, 16, 21, 23, 28, 30). At the screening visit, after subjects have provided informed consent, medical history and clinic visit procedures will be performed. Subjects who meet the study criteria will be instructed to maintain habitual diet and physical activity patterns throughout the study period. Subjects will also be instructed to avoid foods/ beverages that cause Gastrointestinal (GI)-distress, as well as high-fiber foods for the 24 h prior to and throughout each 48 h test period. Additional instructions will include avoiding the use of non-steroidal anti-inflammatory drugs (NSAIDS), antacids, proton pump inhibitors (PPIs), and H2 receptor antagonists for the 48 h prior to the next clinic visit (visit 2, day 0). At the test visits, eligible subjects will undergo clinic visit procedures, including assessment of adverse events (AEs).
At the beginning of each test period (Visits 2, 4, 6, 8, and 10), subjects will arrive at the clinic after a 9-14 h fast and will be administered one serving of their assigned study product to consume within 15 min with a standard breakfast meal (t = 0 h). Subjects will remain in the clinic and will be provided a second serving of their assigned study product to consume within 15 min with a standard lunch meal at t= 4 ± 0.5 h. Subjects will then be provided the third and fourth servings of their assigned study product and instructed to consume the study product in its entirety within 15 min of their also provided afternoon snack, and evening dinner, respectively, and to allow at least 3 h between eating occasions. Compliance with dispensed product and meal consumption will be confirmed with a diet record. Subjects will be also instructed to complete a GI Tolerability Questionnaire the next morning (t=24h) after an overnight fast (9-14h). A Bowel Habits Diary will be completed from the initial study product consumption (t= 0) until the subsequent clinic visit (t= 48 h). Subjects will return to the clinic at t= 48 h (Visits 3, 5, 7, 9, and 11) after an overnight fast (9-14 h) to complete the test period, at which time a 48 h GI Tolerability Questionnaire will also be completed.
A washout period of 7 d will occur between each test period (e.g., before Visits 4, 6, 8, and 10), after which subjects will return to the clinic to cross over to the next study product in their test sequence.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Negative control | Placebo comparator | Other: Negative ControlNo added fiber |
| Positive fiber control | Active comparator | Other: Positive Fiber Control90g positive control fiber |
| Novel fiber 30g | Experimental | Other: Novel Fiber30g novel fiber |
| Novel fiber 60g | Experimental | Other: Novel Fiber60g novel fiber |
| Novel fiber 90g | Experimental | Other: Novel Fiber90g novel fiber |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is male or female, 18-54 years of age, inclusive.
- Subject has body mass index (BMI) ≥18.50 and ≤39.99 kg/m2 at visit 1 (day -7) and has been weight stable (± 4.5 kg) for the previous 3 months.
- Subject is judged to be in good health on the basis of medical history.
- Subject is willing to maintain his or her habitual diet and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period.
- Subject is willing to avoid foods/beverages that cause GI-distress, as well as high-fiber foods for 24 h prior to test visits.
Key exclusion criteria (17 listed)
- Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance).
- History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Recent history (within 6 weeks of screening, visit 1) of constipation (defined as <3 bowel movements per week), and/or diarrhea (defined as ≥3 loose or liquid stools/d).
- Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea.
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS),
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 |
|---|---|---|
| Negative ControlNo added fiber beverage | Other | Negative control |
| Positive Fiber ControlAlso: Polydextrosepositive control fiber supplemented beverage provided over 4 servings | Other | Positive fiber control |
| Novel FiberAlso: Cba-1novel fiber supplemented beverage provided over 4 servings | Other | Novel fiber 30g |
| Novel FiberAlso: Cba-1novel fiber supplemented beverage provided over 4 servings | Other | Novel fiber 60g |
| Novel FiberAlso: Cba-1novel fiber supplemented beverage provided over 4 servings | Other | Novel fiber 90g |
Primary outcome
Composite Gastrointestinal GI Symptom Score among conditions
Time frame: 24 hours
Composite score will be calculated for each intake level as the sum of the ratings of the individual components (abdominal distention/bloating, gas/flatulence, borborygmus/stomach rumbling, and abdominal cramping). The ratings will be coded using a 4-point scale, in which 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
Composite Gastrointestinal GI Symptom Score among conditions
Time frame: 48 hours
Composite score will be calculated for each intake level as the sum of the ratings of the individual components (abdominal distention/bloating, gas/flatulence, borborygmus/stomach rumbling, and abdominal cramping). The ratings will be coded using a 4-point scale, in which 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
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 26 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Fiber in people with Signs and Symptoms, Digestive, run by Cargill.
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 17 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Composite Gastrointestinal GI Symptom Score among conditions (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2015.