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

NCT ID: NCT04930250

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2021-12-21

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)

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oat bran fibre processed with method A

Beverage powder with 12% oat bran processed with method A

Group Type: EXPERIMENTAL

Beverage powder with 12% oat bran processed with method A

Intervention Type: OTHER

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.

Oat bran fibre processed with method B

Beverage powder with 12% oat bran processed with method B

Group Type: EXPERIMENTAL

Beverage powder with 12% oat bran processed with method B

Intervention Type: OTHER

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.

Oat bran fibre processed with method C

Beverage powder with 12% oat bran processed with method C

Group Type: EXPERIMENTAL

Beverage powder with 12% oat bran processed with method C

Intervention Type: OTHER

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.

Minimally-processed oat bran (positive control)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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.

Readily-digestible carbohydrate (negative control)

Beverage powder with readily digestible carbohydrate (Negative Control)

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Readily-digestible carbohydrate (negative control)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

20.13.DAI

Identifier Type: -

Identifier Source: org_study_id