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NCT06630312 · ClinicalTrials.gov registry record · Early Phase 1
Glycemic Response of Whole Beans and Bean Products
A Early Phase 1 study of Healthy and Postprandial Hyperglycemia, sponsored by Iowa State University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06630312: Completed Early Phase 1 study of Healthy and Postprandial Hyperglycemia, sponsored by Iowa State University.
NCT06630312 is a Early Phase 1 study of Healthy and Postprandial Hyperglycemia that has completed, run by Iowa State University. The registered enrollment target is 21 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06630312, a Early Phase 1 study of Healthy and Postprandial Hyperglycemia, has completed, sponsored by Iowa State University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Venous blood sample of glucose
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Alpha galactosidase
Study Locations (1)
Iowa
- Iowa State University - Ames
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2023-10-17 |
| Phase | Early Phase 1 |
What the finished NCT06630312 record still lists
NCT06630312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06630312 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT06630312 about?
NCT06630312 is a clinical study titled "Glycemic Response of Whole Beans and Bean Products". 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 b...
What is the current status of trial NCT06630312?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2023-03-28. Estimated completion is 2023-10-17.
What conditions does trial NCT06630312 study?
This clinical trial studies the following conditions: Healthy, Postprandial Hyperglycemia, Body Mass Index, Normal.
What interventions are being tested in trial NCT06630312?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Alpha galactosidase (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06630312?
This trial is sponsored by Iowa State University, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06630312 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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Where NCT06630312's enrollment target sits among peer trials
21 857th of 1090 higher than 231 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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