Effect of Extruded Cereals Enriched With β-glucan on Postprandial Plasma Glucose and Serum Insulin Responses

NCT05556837 | Completed

• 1 other identifier: INQ-2203
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

β-glucan (BG) is a viscous dietary fiber present in barley and oats that, when added to carbohydrate containing foods, reduces the postprandial glycemic response (PPGR), which is considered to be beneficial to health. In 2011, the European Food Safety Authority (EFSA) concluded that 4g of either oat BG (OBG) or barley BG (BBG) per 30g available carbohydrate (avCHO) is required to obtain a reduction in PPGR, however this is an impractically large amount of BG to incorporate into palatable foods. A recent systematic review and meta-analysis found that doses of OBG well below 4g/30g avCHO can significantly reduce PPGR. It is therefore hypothesized that 25g avCHO portions of cereal containing 1.4-1.5g of either OBG or BBG will elicit a statistically significantly lower PPGR compared to a control cereal containing no BG.

Conditions

Healthy

Keywords

Postprandial glucose; Postprandial insulin; Beta Glucan; Oats; Barley

Outcome Measures

Primary Outcomes (1)

• Postprandial Glucose Incremental Area under the Curve (iAUC) from 0-2 hours

  iAUC, ignoring area below baseline, will be calculated from glucose concentrations in plasma obtained from finger prick blood samples. The mean glucose concentration at -5 and 0 minutes will be taken as the baseline.

  Plasma glucose will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)

Secondary Outcomes (9)

• Postprandial Insulin iAUC from 0-2 hours

  Serum insulin will be measured for 2 hours after consumption of the cereals (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)

• Peak Rise of glucose

  Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)

• Peak Rise of insulin

  Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)

• Gmax

  Glucose will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)

• Imax

  Insulin will be measured over 2 hours postprandially (timepoints: -5, 0, 15, 30, 45, 60, 90, and 120 minutes)

Study Arms (3)

Control Cereal

PLACEBO COMPARATOR

A portion of cereal (25g available carbohydrate) that contains no beta-glucan

Other: Control Cereal

OBG Cereal

EXPERIMENTAL

A portion of cereal (25g available carbohydrate) that contains approximately 1.4g of oat beta-glucan (OBG)

Other: OBG Cereal

BBG Cereal

EXPERIMENTAL

A portion of cereal (25g available carbohydrate) that contains approximately 1.4g of barley beta-glucan (BBG)

Other: BBG Cereal

Interventions

Control Cereal OTHER

A portion of cereal (25g available carbohydrate), served with 125ml of 2% milk and 250ml water, will be fed to participants and postprandial glucose and insulin will be measured

Control Cereal

OBG Cereal OTHER

A portion of cereal (25g available carbohydrate) containing OBG, served with 125ml of 2% milk and 250ml of water, will be fed to participants and postprandial glucose and insulin will be measured

OBG Cereal

BBG Cereal OTHER

A portion of cereal (25g available carbohydrate) containing BBG, served with 125ml of 2% milk and 250ml of water, will be fed to participants and postprandial glucose and insulin will be measured

BBG Cereal

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are non-pregnant, non-lactating aged 20-65 years of age, inclusive.
• Body mass index 18.0 to 29.9 kg/m², inclusive.
• Nonsmokers (tobacco, cannabis, vaping).
• Fasting glucose concentration \<7.0 mmol/L (126 mg/dL), determined by a fasting finger-stick blood sample (plasma) at screening.
• Willing to abstain from unusual levels of food intake, unusual or strenuous exercise, smoking or consuming alcoholic drinks 24 hours before study days.
• Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
• Willing to comply with the protocol.
• Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as the Ontario Health Insurance Plan.

You may not qualify if:

• Systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at screening.
• Change in body weight of \>3.5kg (\>7.7 lbs.) within 4 weeks of the screening visit.
• Practicing any extreme dietary habits, as judged by the Investigator (i.e., Atkins diet, very high protein diet, etc.).
• Major trauma or major medical or surgical event within 3 months of screening.
• History or presence of clinically important endocrine, cardiovascular, pulmonary, biliary, or gastrointestinal disorders.
• The use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, thiazolidinediones, metformin, and systemic corticosteroids, or with any condition or use of any medication which might, in the opinion of the Qualified Investigator (QI), either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
• Use of supplements containing chromium (intended for glucose management), ginseng or cinnamon, within 3 weeks of screening.
• Changes in the doses of permissible prescription drugs within 3 months of screening or changes in the doses of over-the-counter drugs or permissible supplements within 3 weeks of screening.
• History of cancer in the prior two years, except for non-melanoma skin cancer.
• Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse, where alcohol abuse is defined as \> 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
• Known intolerance, sensitivity, or allergy to any ingredients in the study test meals.
• Unwillingness or inability to comply with the experimental procedures and to follow INQUIS health and safety policies.
• Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• INQUIS Clinical Research: collaborator
• Cereal Partners Worldwide: collaborator

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Location

Study Officials

• Thomas Wolever, DM, PhD

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blinded; the participants, those serving the participants and those doing the biochemical analysis, entering data, and performing the statistical analysis will be blinded to the nature of the test meals. The codes identifying the test meals will be kept in a sealed opaque envelope at INQUIS and will be opened only if necessary to assist in the diagnosis and management of a serious adverse event. Test meal identity on study documents and blood tubes will be the code numbers on the test food packages. Thus, the identity of the test meals will be double-blinded. The codes will be broken once the database for plasma glucose and serum insulin has been cleaned, locked, and sent to the sponsor.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a double-blinded, randomized, crossover design with all subjects completing all 3 tests.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: March 4, 2024
• Primary Completion: April 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)