Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response

NCT05291806 | Completed

• 1 other identifier: TSP2201
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.

Conditions

Blood Glucose Response

Outcome Measures

Primary Outcomes (1)

• Postprandial capillary blood glucose iAUC (0-120 min)

  The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

Secondary Outcomes (11)

• Postprandial capillary blood glucose Cmax

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

• Postprandial capillary blood glucose Tmax

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

• Fasting capillary blood glucose

  Outcome measures will be assessed just before the standardized meal is consumed.

• Postprandial capillary blood glucose iAUC (0-60 min)

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

• Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

Other Outcomes (8)

• Fasting GLP-1

  Outcome measures will be assessed just before the standardized meal is consumed.

• GLP-1 iAUC(0-120 min)

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

• GLP-1 iAUC(0-60 min)

  Outcome measures will be assessed just before and immediately after the standardized meal is consumed.

Study Arms (4)

Reference

PLACEBO COMPARATOR

Other: Reference Product

Whole cereal kernels Dose A

ACTIVE COMPARATOR

Other: Wholegrain product Dose A

Whole cereal kernels Dose B

ACTIVE COMPARATOR

Other: Wholegrain product Dose B

Cut cereal kernels Dose A

ACTIVE COMPARATOR

Other: Wholegrain product Dose A, cut kernels

Interventions

Reference Product OTHER

This intervention is based on white rice.

Reference

Wholegrain product Dose A OTHER

This wholegrain intervention contains whole cereal kernels.

Whole cereal kernels Dose A

Wholegrain product Dose B OTHER

This wholegrain intervention contains whole cereal kernels.

Whole cereal kernels Dose B

Wholegrain product Dose A, cut kernels OTHER

This wholegrain intervention contains cut cereal kernels.

Cut cereal kernels Dose A

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, 35 to 65 years of age
• BMI 18.5-29.9 kg/m2
• Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
• Healthy as determined by medical history and information provided by the volunteer.
• Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
• Has given voluntary, written, informed consent to participate in the study.

You may not qualify if:

• Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
• Women who are pregnant or breast feeding
• Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
• Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
• Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
• Use of antibiotics within 2 weeks of enrollment
• Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
• Allergy to ingredients included in investigational product, reference, or standardized meal
• Participants restricted to a vegetarian or vegan diet
• Intolerance to gluten
• Individuals who are averse to venous catheterization or capillary blood sampling
• Currently active smokers (or using other tobacco products, and e-cigarettes)
• Unstable medical conditions as determined by QI
• Participation in other clinical research trials
• Individuals who are cognitively impaired and/or who are unable to give informed consent

Sponsors & Collaborators

• Aventure AB: lead

Study Sites (1)

Aventure AB

Lund, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: March 17, 2022
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)