National University Hospital
Singapore, 150054
NCT Number: NCT04930250
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.
Looking for future studies?
Notify Me24 year–39 year
All sexes
Interventional
Not applicable
Singapore, 150054
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: through study completion, an average of 7 months
Postprandial glycemic response reflected by 3-hour area under the plasma concentration versus time curve (AUC) assessed over all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Time frame: through study completion, an average of 7 months
Postprandial glycemic response by the peak plasma concentration (Cmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Time frame: through study completion, an average of 7 months
Postprandial glycemic response reflected by time to achieve the peak plasma concentration (Tmax) assessed over a 3-hour period by all cross-sectional blood glucose values (i.e. T0/T15/T30/T45/T60/T90/T120/T180).
Time frame: through study completion, an average of 7 months
PPIR over a 3-hour period
Time frame: through study completion, an average of 7 months
Postprandial blood GIP over a 3-hour period
Time frame: through study completion, an average of 7 months
Postprandial blood GLP-1 over a 3-hour period
Time frame: through study completion, an average of 7 months
Gastric emptying rate measured through postprandial blood paracetamol concentration over a 4-hour period
Time frame: through study completion, an average of 7 months
Satiety assessed via a Visual Analogue Scale questionnaire from 0-10 over a 4-hour period, with 0 being least satiated and 10 being most satiated
Time frame: through study completion, an average of 7 months
Gastrointestinal comfort assessed via a Visual Analogue Scale questionnaire from 0-10 over a 4-hour period, with 0 being lowest discomfort and 10 being greatest discomfort
Time frame: through study completion, an average of 7 months
Fermentability by colonic bacteria will be assessed via breath hydrogen and methane (ppm) levels over a 4-hour period
Société des Produits Nestlé (SPN)
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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