Effect of Various Processed Oat Bran in a Beverage Matrix on Glycaemic Health

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Other: Placebo Comparator: Readily-digestible carbohydrate (negative control); Other: Placebo Comparator: Minimally-processed oat bran (Positive Control); Other: Beverage powder with 12% oat bran processed with method B; Other: Beverage powder with 12% oat bran processed with method A; Other: Beverage powder with 12% oat bran processed with method C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04930250

20.13.DAI

Details and patient eligibility

About

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.

Full 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)

Enrollment: 20 patients

Sex: All

Ages: 24 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 5 patient groups, including a placebo group

Oat bran fibre processed with method A

Experimental group

Description:

Beverage powder with 12% oat bran processed with method A

Treatment:

Other: Beverage powder with 12% oat bran processed with method A

Oat bran fibre processed with method B

Experimental group

Description:

Beverage powder with 12% oat bran processed with method B

Treatment:

Other: Beverage powder with 12% oat bran processed with method B

Oat bran fibre processed with method C

Experimental group

Description:

Beverage powder with 12% oat bran processed with method C

Treatment:

Other: Beverage powder with 12% oat bran processed with method C

Minimally-processed oat bran (positive control)

Active Comparator group

Description:

Beverage powder with minimally-processed oat bran (Positive Control)

Treatment:

Other: Placebo Comparator: Minimally-processed oat bran (Positive Control)

Readily-digestible carbohydrate (negative control)

Placebo Comparator group

Description:

Beverage powder with readily digestible carbohydrate (Negative Control)

Treatment:

Other: Placebo Comparator: Readily-digestible carbohydrate (negative control)