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Completed

NCT Number: NCT04930250

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

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.

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Key information

Conditions

Age range

24 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 150054

About this study

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:

  • Beverage powder with 12% oat bran processed with method A (Test Product: TP-1)
  • Beverage powder with 12% oat bran processed with method B (Test Product: TP-2)
  • Beverage powder with 12% oat bran processed with method C (Test Product: TP-3)
  • Beverage powder with 12% minimally-processed oat bran (Positive Control) (Test Product: TP-PC)
  • Beverage powder without oat bran (Negative Control) (Test Product: TP-NC)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Has donated blood in the past one month
  • Hierarchical link with the research team members
  • Participating in another clinical study

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

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

    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).

  2. Postprandial glycemic response - Peak Plasma Concentration (Cmax)

    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).

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

    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).

Secondary outcomes

  1. Postprandial insulin response (PPIR)

    Time frame: through study completion, an average of 7 months

    PPIR over a 3-hour period

  2. Postprandial blood gastric inhibitory polypeptide (GIP)

    Time frame: through study completion, an average of 7 months

    Postprandial blood GIP over a 3-hour period

  3. Postprandial blood glucagon-like peptide 1 (GLP-1)

    Time frame: through study completion, an average of 7 months

    Postprandial blood GLP-1 over a 3-hour period

  4. Gastric emptying rate

    Time frame: through study completion, an average of 7 months

    Gastric emptying rate measured through postprandial blood paracetamol concentration over a 4-hour period

  5. Satiety

    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

  6. Gastrointestinal comfort

    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

  7. Ingredient fermentability by colonic bacteria

    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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • National University Hospital, Singapore
  • National University of Singapore

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Sep 22, 2022

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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