The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children

NCT05213494 | Completed DMC

• 1 other identifier: BIO-2108
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at levels that could contribute to closing the fiber gap. The dose response effects of PROMITOR® Soluble Corn Fiber in healthy children will also be compared.

Conditions

Gastrointestinal Tolerance

Keywords

digestion, fiber, tolerance,

Outcome Measures

Primary Outcomes (1)

• GI Tolerance Composite Score

  The electronic Bedtime GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring from start of study product consumption in the morning until bedtime. The electronic Morning GITQ contains a series of questions regarding the presence and severity of GI symptoms occurring from bedtime until immediately prior to the consumption of study product the next morning. Individual GI symptoms include: gas/flatulence, abdominal cramping, abdominal distention/bloating, borborygmus/stomach rumbling, burping, and nausea and their severity is ranked on a 4-point scale ranging from none to severe.

  10 day study period

Secondary Outcomes (1)

• Effects of consuming soluble corn fiber on individual GI symptoms

  Baseline, Days 1,2, 3,5,7 and 10 of each study product period.

Other Outcomes (1)

• Dose response effects of soluble corn fiber on GI tolerance, stool consistency and bowel habits and fecal microbiome

  up to 10 days

Study Arms (5)

Low-dose inulin

ACTIVE COMPARATOR

3-5 years old: 3g of fiber/day from inulin mixed in a beverage 6-9 years old: 5g of fiber/day from inulin mixed in a beverage

Other: Inulin

Low-dose soluble corn fiber

EXPERIMENTAL

3-5 years old: 3g of fiber/day from soluble corn fiber mixed in a beverage 6-9 years old: 5g of fiber/day from soluble corn fiber mixed in a beverage

Other: soluble corn fiber

High-dose inulin

ACTIVE COMPARATOR

3-5 years old: 6g of fiber/day from inulin mixed in a beverage 6-9 years old: 8g of fiber/day from inulin mixed in a beverage

Other: Inulin

High-dose soluble corn fiber

EXPERIMENTAL

3-5 years old: 6g of fiber/day from soluble corn fiber mixed in a beverage 6-9 years old: 8g of fiber/day from soluble corn fiber mixed in a beverage

Other: soluble corn fiber

Baseline

NO INTERVENTION

3-9 years old: pre-intervention.

Interventions

Inulin OTHER

Inulin, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.

High-dose inulin; Low-dose inulin

soluble corn fiber OTHER

soluble corn fiber, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.

High-dose soluble corn fiber; Low-dose soluble corn fiber

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, 3-9 years of age, inclusive at Visit 1 (Day -7)
• Potty trained
• Bowel movement at least every other day.
• Regularly consumes breakfast (at least 5 times/week) and agrees to consume breakfast every day during each test period.
• Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
• No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
• Caregiver understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator and subject provides informed assent.

You may not qualify if:

• Regular (\>2/week) moderate to severe GI symptoms (as reported by subject and/or caregiver at Visit 1, Day -7). Mild and infrequent (≤ 2/week) GI symptoms are allowed.
• Subject will be away from caregiver for more than 1 day during the 3-day baseline period (Days -3, -2, and -1) and \>48 consecutive hours during the 10 days of study product consumption during each test period. Goal is to recruit subjects who will be with their caregiver all or most of the time to minimize missing data.
• Clinically important GI conditions that would potentially interfere with the evaluation of the study product \[e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, gastroparesis, and clinically significant lactose and gluten intolerance or other food or ingredient allergies which includes allergies to milk, eggs, peanuts, tree nuts, wheat and soy (Appendix 9)\].
• Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥ 3 loose or liquid stools/day).
• Caregiver-reported history (within 4 weeks of Visit 1; Day -7) of any constipation (\<3 bowel movement/week) and diarrhea (≥3 of more loose stools/day) at the discretion of the Clinical Investigator.
• Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic, neurological (e.g., depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
• Uncontrolled hypertension determined by the blood pressure measured at Visit 1 (Day -7) and defined as (https://www.emedicinehealth.com/pediatric\_vital\_signs/article\_em.htm):
• Children 3-5 years old: Systolic blood pressure \>107 mm Hg and diastolic blood pressure \>71 mm Hg
• Children 6-9 years old: Systolic blood pressure \>110 mm Hg and diastolic blood pressure \>73 mm Hg One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -7), in the judgment of the Clinical Investigator.
• Extreme dietary habits as determined using the Diet Questionnaire (Appendix 2) and at the discretion of the Clinical Investigator.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Major trauma or any other surgical event within 3 months of Visit 1 (Day -7).
• Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Day -7). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Day -7).\*
• Weight loss or gain \>4.5 kg in the 3 months prior to Visit 1 (Day -7).
• Currently or planning to be on a weight loss regimen during the study.

Sponsors & Collaborators

• Tate & Lyle: lead
• Biofortis Innovation Services: collaborator

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Related Publications (13)

• Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2.

  PMID: 31893959 BACKGROUND

• Boler BM, Serao MC, Bauer LL, Staeger MA, Boileau TW, Swanson KS, Fahey GC Jr. Digestive physiological outcomes related to polydextrose and soluble maize fibre consumption by healthy adult men. Br J Nutr. 2011 Dec;106(12):1864-71. doi: 10.1017/S0007114511002388. Epub 2011 May 31.

  PMID: 21736814 BACKGROUND

• So D, Whelan K, Rossi M, Morrison M, Holtmann G, Kelly JT, Shanahan ER, Staudacher HM, Campbell KL. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Jun 1;107(6):965-983. doi: 10.1093/ajcn/nqy041.

  PMID: 29757343 BACKGROUND

• Ho J, Nicolucci AC, Virtanen H, Schick A, Meddings J, Reimer RA, Huang C. Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4427-4440. doi: 10.1210/jc.2019-00481.

  PMID: 31188437 BACKGROUND

• Housez B, Cazaubiel M, Vergara C, Bard JM, Adam A, Einerhand A, Samuel P. Evaluation of digestive tolerance of a soluble corn fibre. J Hum Nutr Diet. 2012 Oct;25(5):488-96. doi: 10.1111/j.1365-277X.2012.01252.x. Epub 2012 Jun 6.

  PMID: 22672058 BACKGROUND

• Karalus M, Clark M, Greaves KA, Thomas W, Vickers Z, Kuyama M, Slavin J. Fermentable fibers do not affect satiety or food intake by women who do not practice restrained eating. J Acad Nutr Diet. 2012 Sep;112(9):1356-1362. doi: 10.1016/j.jand.2012.05.022. Epub 2012 Jul 6.

  PMID: 22771185 BACKGROUND

• Klosterbuer AS, Hullar MA, Li F, Traylor E, Lampe JW, Thomas W, Slavin JL. Gastrointestinal effects of resistant starch, soluble maize fibre and pullulan in healthy adults. Br J Nutr. 2013 Sep 28;110(6):1068-74. doi: 10.1017/S0007114513000019. Epub 2013 Feb 7.

  PMID: 23388502 BACKGROUND

• Klurfeld DM, Davis CD, Karp RW, Allen-Vercoe E, Chang EB, Chassaing B, Fahey GC Jr, Hamaker BR, Holscher HD, Lampe JW, Marette A, Martens E, O'Keefe SJ, Rose DJ, Saarela M, Schneeman BO, Slavin JL, Sonnenburg JL, Swanson KS, Wu GD, Lynch CJ. Considerations for best practices in studies of fiber or other dietary components and the intestinal microbiome. Am J Physiol Endocrinol Metab. 2018 Dec 1;315(6):E1087-E1097. doi: 10.1152/ajpendo.00058.2018. Epub 2018 Aug 21.

  PMID: 30130151 BACKGROUND

• Molly K, Vande Woestyne M, Verstraete W. Development of a 5-step multi-chamber reactor as a simulation of the human intestinal microbial ecosystem. Appl Microbiol Biotechnol. 1993 May;39(2):254-8. doi: 10.1007/BF00228615.

  PMID: 7763732 BACKGROUND

• Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.

  PMID: 20090313 BACKGROUND

• Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20.

  PMID: 23427334 BACKGROUND

• Van Hul M, Karnik K, Canene-Adams K, De Souza M, Van den Abbeele P, Marzorati M, Delzenne NM, Everard A, Cani PD. Comparison of the effects of soluble corn fiber and fructooligosaccharides on metabolism, inflammation, and gut microbiome of high-fat diet-fed mice. Am J Physiol Endocrinol Metab. 2020 Oct 1;319(4):E779-E791. doi: 10.1152/ajpendo.00108.2020. Epub 2020 Aug 24.

  PMID: 32830554 BACKGROUND

• Whisner CM, Martin BR, Nakatsu CH, McCabe GP, McCabe LD, Peacock M, Weaver CM. Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. Br J Nutr. 2014 Aug 14;112(3):446-56. doi: 10.1017/S0007114514000981. Epub 2014 May 22.

  PMID: 24848974 BACKGROUND

Related Links

• Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids.
• What We Eat in America, NHANES 2017-2018.
• World Health Organization. Fact sheet: Diarrhoeal disease

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Kathleen Kelley

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 28, 2022
• Study Start: May 20, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)