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NCT00988403 · ClinicalTrials.gov registry record · NA
Investigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Dose Response Study
A NA study of Healthy Volunteers, sponsored by Augusta University.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00988403 is a NA study of Healthy Volunteers that has completed, run by Augusta University. The registered enrollment target is 19 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00988403, a NA study of Healthy Volunteers, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
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, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
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.
NCT00988403 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
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.
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).
Who is sponsoring clinical trial NCT00988403?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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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Related
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