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NCT03255603
Gastrointestinal Assessment of Three Novel RS4
NA trial testing Resistant Starch Type 4 Supplementation in Diet Modification in 40 participants. Completed in 22 December 2018.
28 February 2018
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 1 September 2017 |
| Primary completion | 28 February 2018 |
| Estimated completion | 22 December 2018 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Resistant Starch Type 4 Supplementation
- Resistant Starch Type 4 Supplementation
- Resistant Starch Type 4 Supplementation
- Digestible Starch Supplementation
Conditions studied
- Diet Modification — all drugs for Diet Modification →
Sponsor
University of Alberta
Who can join
Adults 18 to 50, any sex, with Diet Modification. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The rates of chronic diseases like obesity, diabetes, and heart disease are rising across the world. This is especially true in industrialized countries like Canada and the USA. Even though there are many possible causes for these increases. One prominent cause is our refined diet, which greatly lacks dietary fiber. This 'fiber gap' between the amount of fiber actually eaten and the amount that should be eaten is likely promoting these diseases. It is known that a high fiber diet can benefit health and the health of the gut bacteria. It is also know that these gut microbes can help cause and prevent diseases. When fiber is eaten, it gets broken down not by us, but by our gut microbes. During this process by-products called short-chain fatty acids (SCFA) are made. These SCFA have been shown to promote health. Therefore, it is thought that fiber changes the gut microbes to produce more SCFA, which may improve overall health. In order to aid our microbes and improve our health we need to find ways to reduce this 'fiber gap'. One possibility is to add fiber to our refined diet. To do so we must first learn how different fibers perform in our gut. This includes how our gut tolerates increasing amounts of fiber, and how our microbes respond. The purpose of this study is to learn how different types of resistant starch perform in our gut, including gastrointestinal tolerance. By doing so we will determine the ideal dose and type of these fibers to use in future studies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03255603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03255603 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alberta
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03255603.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing