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NCT06204666
Hemp Fiber Ingestion and Gut Permeability After Exercise
NA trial testing High Dose Hemp Fiber Bar in Gastrointestinal Dysfunction in 25 participants. Completed in 15 September 2024.
1 July 2024
Quick facts
| Lead sponsor | Appalachian State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 25 |
| Start date | 9 December 2023 |
| Primary completion | 1 July 2024 |
| Estimated completion | 15 September 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- High Dose Hemp Fiber Bar
- Low Dose Hemp Fiber Bar
- Placebo
Conditions studied
- Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →
- Metabolic Disturbance — all drugs for Metabolic Disturbance →
Sponsor
Appalachian State University
Who can join
Adults 18 to 65, any sex, with Gastrointestinal Dysfunction or Metabolic Disturbance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Two bioactive compounds, N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT), have been investigated for potential gut health benefits. The shells of hemp seeds are a rich source of NCT and NFT. The hypothesis for this project is that ingestion of a hemp fiber bar containing NCT and NFT will mitigate exercise-induced increases in gut permeability. This study will examine the efficacy of 2-weeks ingestion of a hemp fiber bar (high and low doses) in moderating exercise-induced gut permeability using a randomized crossover trial. Objective #1: To conduct a randomized crossover trial using placebo-controlled, double-blind procedures with 20 cyclists who will in random order ingest a hemp fiber bar supplement (high and low doses) or placebo each day for two weeks prior to an exercise challenge (2.25 hours of intensive cycling). Objective #2: To determine if hemp fiber bar supplementation attenuates exercise-induced gut permeability using several outcome measures including plasma lactulose to 13C mannitol (L:M) ratio and plasma intestinal fatty acid binding protein (I-FABP) as markers of gastrointestinal permeability and mucosal damage, respectively. Shifts in thousands of metabolites will be measured via untargeted metabolomics to provide additional gut permeability biomarkers and help reveal underlying mechanisms.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Selective Influence of Hemp Fiber Ingestion on Post-Exercise Gut Permeability: A Metabolomics-Based Analysis.
Nieman DC, Sakaguchi CA, Williams JC, Pathmasiri W, et al · · 2025 · cited 1× · PMID 40284247 · DOI 10.3390/nu17081384
Verify or expand the search:
- PubMed search for NCT06204666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT06204666 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Appalachian State University
- Last refreshed: 26 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/NCT06204666.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing