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Investigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Dose Response Study
NCT00988403 · View on ClinicalTrials.gov ↗
Study Summary
Fructan is a carbohydrate polymer that is composed of fructose and a terminal glucose moiety . Fructans are naturally found in artichokes (6.1 grams/serving), leeks (5.9 grams/serving), onion bulbs (1.01 grams/serving), flour (4.0 grams/serving), garlic (.52 grams/serving), watermelon (.92 grams/serving), nectarines (.27 grams/serving) and white peaches (.50 grams/serving). Because fructans are present in many common foods, people typically ingest high levels of fructan. The most common structural forms of fructan are inulin, levanare and geraminan . The human body absorbs only 5% of fructan, however it is estimated that the daily intake in the USA may vary between 1-20 grams, and possibly higher due to the recently discovered benefits of inulins . Dietary trends indicate that high levels of fructans are common in the European and American diet, as more wheat based products such as breakfast cereal, pasta, and bread are consumed. Fructans may not be well tolerated by some subjects and its malabsorption may result in gastrointestinal (GI) symptoms such as heartburn, belching, abdominal pain, diarrhea, gas, and bloating; and this is especially true when higher doses are ingested. Unlike glucose, fructans are not efficiently digested or absorbed by the small intestine. The mechanism for malabsorption is related to the inability to hydrolyze glycosidic linkages in the complex polysaccharide, resulting in the delivery of malabsorbed fructans to the large bowel1. In the colon, the malabsorbed fructans are rapidly fermented, and byproducts of this fermentation include H2, CH4, and other gases that may contribute to bowel symptoms. Furthermore, the small molecular nature of fructans results in an osmotic effect which draws more water into the small intestine and causes bloating and diarrhea. Ingestion of high doses of fructans can cause symptoms in healthy adults, but may cause more bothersome symptoms in subjects with Irritable Bowel Syndrome (IBS). Earlier studies have
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Fructan - 7.5
- DIETARY_SUPPLEMENT Fructan - 10
- DIETARY_SUPPLEMENT Fructan - 12.5
- DIETARY_SUPPLEMENT Fructan -- 5 grams
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-06 |
| Est. Completion | 2018-07-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988403
The ClinicalTrials.gov registry entry for NCT00988403 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions — of which Fructan - 7.5 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00988403 reports 1 study location spanning 1 distinct geographic area — top geographies include Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00988403 about?
NCT00988403 is a clinical study titled "Investigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Dose Response Study". Fructan is a carbohydrate polymer that is composed of fructose and a terminal glucose moiety . Fructans are naturally found in artichokes (6.1 grams/serving), leeks (5.9 grams/serving), onion bulbs (1.01 grams/serving), flour (4.0 grams/serving), garlic (.52 grams/serving), watermelon (.92 grams/ser...
What is the current status of trial NCT00988403?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2009-06. Estimated completion is 2018-07-20.
What conditions does trial NCT00988403 study?
This clinical trial studies the following conditions: Healthy Volunteers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00988403?
The interventions under investigation include: Fructan - 7.5 (DIETARY_SUPPLEMENT), Fructan - 10 (DIETARY_SUPPLEMENT), Fructan - 12.5 (DIETARY_SUPPLEMENT), Fructan -- 5 grams (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00988403?
This trial is sponsored by Augusta University, which has 126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00988403 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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