Trials / Completed
CompletedNCT04930250
Effect of Various Processed Oat Bran in a Beverage Matrix on Glycaemic Health
A Randomised, Double-blind, Controlled, Crossover Study to Evaluate the Acute Effect on Glycemic Response and Related Biomarkers When Replacing Rapidly Digested Carbohydrates by β-glucan-rich Oat Bran Processed in Different Conditions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 24 Years – 39 Years
- Healthy volunteers
- Accepted
Summary
Whilst a cause-and-effect relationship between consumption of oat ß-glucans and reduction in PPGR has been demonstrated, little is understood about its: * Application to liquid matrices: There are few studies which looked into the effect of a dose of ß-glucan applicable to beverages. Previous studies have explored oat ß-glucan doses between 2g to 13g per serving of test product (Note: the oat ß-glucan dose for the proposed trial is \<2g). * Impact following processing: Collectively, oat processing, ß-glucan structure and its physiological impact on PPGR are closely linked. Some studies have investigated the effect of oat processing or dosage on PPGR, but to our knowledge, no study has systematically characterised the effect of processing on oat structure, and clinically measured its subsequent impact on PPGR.
Detailed description
The proposed study is a randomised, double blind, controlled, crossover trial to investigate the postprandial effects on glycemic response and related biomarkers/biological surrogates in five test product beverages: This study will investigate the post-prandial effects of five test products, including two controls: 1. Beverage powder with 12% oat bran processed with method A (Test Product: TP-1) 2. Beverage powder with 12% oat bran processed with method B (Test Product: TP-2) 3. Beverage powder with 12% oat bran processed with method C (Test Product: TP-3) 4. Beverage powder with 12% minimally-processed oat bran (Positive Control) (Test Product: TP-PC) 5. Beverage powder without oat bran (Negative Control) (Test Product: TP-NC)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Beverage powder with 12% oat bran processed with method A | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
| OTHER | Beverage powder with 12% oat bran processed with method B | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
| OTHER | Beverage powder with 12% oat bran processed with method C | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
| OTHER | Placebo Comparator: Minimally-processed oat bran (Positive Control) | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
| OTHER | Placebo Comparator: Readily-digestible carbohydrate (negative control) | 50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits. |
Timeline
- Start date
- 2021-07-19
- Primary completion
- 2021-12-21
- Completion
- 2021-12-21
- First posted
- 2021-06-18
- Last updated
- 2022-09-22
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT04930250. Inclusion in this directory is not an endorsement.