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

NCT04930250 | Completed

• 1 other identifier: 20.13.DAI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Postprandial glycemic response - Area under the plasma concentration versus time curve (AUC)

  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).

  through study completion, an average of 7 months

• Postprandial glycemic response - Peak Plasma Concentration (Cmax)

  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).

  through study completion, an average of 7 months

• Postprandial glycemic response - Time to Peak Plasma Concentration (Tmax)

  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).

  through study completion, an average of 7 months

Secondary Outcomes (7)

• Postprandial insulin response (PPIR)

  through study completion, an average of 7 months

• Postprandial blood gastric inhibitory polypeptide (GIP)

  through study completion, an average of 7 months

• Postprandial blood glucagon-like peptide 1 (GLP-1)

  through study completion, an average of 7 months

• Gastric emptying rate

  through study completion, an average of 7 months

• Satiety

  through study completion, an average of 7 months

Study Arms (5)

Oat bran fibre processed with method A

EXPERIMENTAL

Beverage powder with 12% oat bran processed with method A

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

Oat bran fibre processed with method B

EXPERIMENTAL

Beverage powder with 12% oat bran processed with method B

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

Oat bran fibre processed with method C

EXPERIMENTAL

Beverage powder with 12% oat bran processed with method C

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

Minimally-processed oat bran (positive control)

ACTIVE COMPARATOR

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

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

Readily-digestible carbohydrate (negative control)

PLACEBO COMPARATOR

Beverage powder with readily digestible carbohydrate (Negative Control)

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

Interventions

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

Beverage powder with 12% oat bran processed with method B 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 C 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

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

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

Eligibility Criteria

• Age: 24 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants, age between 24 and 39 years
• Healthy individuals with no comorbidities or on regular medication
• BMI between 18.5-25 kg/m2
• Able to understand and willing to sign an informed consent form in English
• Regularly consume breakfast
• Able and willing to consume 330ml of liquid in 10 minutes
• For female participants, have a regular menstrual cycle

You may not qualify if:

• Known food allergies or intolerances specifically to gluten, milk, lactose or any grains
• Known drug allergies specifically paracetamol
• Known sensitivity or has had an adverse reaction to paracetamol and non-steroidal anti-inflammatory drugs (NSAID) in the past
• Individuals with regular prescriptions or regularly consume medication (at least once a month), including alternative medicine (e.g. traditional Chinese medicine)
• Had been diagnosed or with a history of any metabolic disease or disorders, including diabetes, gestational diabetes and hypertension
• Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
• Had been hospitalised in the 3 months prior to the study.
• Pregnant or lactating women, or planning to conceive in the next 3 months
• 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.
• Smokers
• Poor peripheral venous access based on past experiences with blood draw
• Significant change in weight (≥ 3 kg body weight) in the past 3 months
• Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
• Currently on a specialised diet e.g. vegetarian, vegan, weight loss plan, high protein diet
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• National University Hospital, Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 150054, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The test products are coded by group coding (A - E).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 18, 2021
• Study Start: July 19, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

SG (1)