Healthy
Conditions
Brief 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)
Interventions
OTHERBeverage 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.
OTHERBeverage 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.
OTHERBeverage 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.
OTHERPlacebo 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.
OTHERPlacebo 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.
Sponsors
National University Hospital, Singapore
National University of Singapore
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The test products are coded by group coding (A - E).
Intervention model description
Randomised controlled, double-blind, full crossover study conducted in an acute setting. 20 subjects will receive 5 test products, over 5 separate test visits in a crossover design.
Eligibility
Sex/Gender
ALL
Age
24 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female participants, age between 24 and 39 years 2. Healthy individuals with no comorbidities or on regular medication 3. BMI between 18.5-25 kg/m2 4. Able to understand and willing to sign an informed consent form in English 5. Regularly consume breakfast 6. Able and willing to consume 330ml of liquid in 10 minutes 7. For female participants, have a regular menstrual cycle
Exclusion criteria
1. Known food allergies or intolerances specifically to gluten, milk, lactose or any grains 2. Known drug allergies specifically paracetamol 3. Known sensitivity or has had an adverse reaction to paracetamol and non-steroidal anti-inflammatory drugs (NSAID) in the past 4. Individuals with regular prescriptions or regularly consume medication (at least once a month), including alternative medicine (e.g. traditional Chinese medicine) 5. Had been diagnosed or with a history of any metabolic disease or disorders, including diabetes, gestational diabetes and hypertension 6. Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis 7. Had been hospitalised in the 3 months prior to the study. 8. Pregnant or lactating women, or planning to conceive in the next 3 months 9. Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit. 10. Smokers 11. Poor peripheral venous access based on past experiences with blood draw 12. Significant change in weight (≥ 3 kg body weight) in the past 3 months 13. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week 14. Currently on a specialised diet e.g. vegetarian, vegan, weight loss plan, high protein diet 15. Unwilling to refrain from consuming fibre or prebiotic supplements, high fibre ingredients and more than 5 servings of fruits and vegetables per day over the length of the study. 16. Has donated blood in the past one month 17. Hierarchical link with the research team members 18. Participating in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC) | 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). |
| Postprandial glycemic response - Peak Plasma Concentration (Cmax) | 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). |
| Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial insulin response (PPIR) | through study completion, an average of 7 months | PPIR over a 3-hour period |
| Postprandial blood gastric inhibitory polypeptide (GIP) | through study completion, an average of 7 months | Postprandial blood GIP over a 3-hour period |
| Postprandial blood glucagon-like peptide 1 (GLP-1) | through study completion, an average of 7 months | Postprandial blood GLP-1 over a 3-hour period |
| Gastric emptying rate | through study completion, an average of 7 months | Gastric emptying rate measured through postprandial blood paracetamol concentration over a 4-hour period |
| Satiety | 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 |
| Gastrointestinal comfort | 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 |
| Ingredient fermentability by colonic bacteria | 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 |
Countries
Singapore
Outcome results
None listed