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NCT06630312: BH-GLY
Glycemic Response of Whole Beans and Bean Products
EARLY_PHASE1 trial testing Alpha galactosidase in Healthy in 21 participants. Completed in 17 October 2023.
27 June 2023
Quick facts
| Lead sponsor | Iowa State University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 21 |
| Start date | 28 March 2023 |
| Primary completion | 27 June 2023 |
| Estimated completion | 17 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alpha galactosidase
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
- Body Mass Index, Normal — all drugs for Body Mass Index, Normal →
- Postprandial Hyperglycemia — all drugs for Postprandial Hyperglycemia →
Sponsor
Iowa State University
Who can join
Adults 21 to 34, any sex, with Healthy or Body Mass Index, Normal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main goal of this clinical trial is to learn if alpha-galactosidase (tradename Beano) changes in post-prandial (after-meal) blood glucose after eating whole cooked whole pulses or pulse-based pasta products in comparison to the same foods without alpha-galactosidase. Comparison of postprandial blood insulin and triglyceride levels, appetite, and gastrointestinal symptoms of flatulence, bloating, and stool changes will be evaluated by comparisons of the alpha-galactosidase and the pulse form (whole vs. pasta). In addition to blood glucose, such as flatulence and bloating, postprandial glucose, insulin, and appetite of individuals. The study design is a 4x4 crossover and the population is healthy volunteers aged 21-34 with normal glucose response and body weight. The primary hypothesis is that alpha-galactosidase will cause increased postprandial blood glucose for both whole and pasta pulse foods. The secondary hypothesis is that gastrointestinal symptoms will be less for both meals with the alpha-galactosidase. Other comparisons are exploratory. Participants will come in fasting for one morning per week and receive the food treatments in randomized order. Test measurements will be taken over a four hour period.
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 NCT06630312
- 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 NCT06630312 (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 Iowa State University
- Last refreshed: 8 October 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/NCT06630312.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing