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Completed

NCT Number: NCT05824195

Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables

The overall goal is to increase the knowledge that can be used for the development of food products with antidiabetic properties, with the aim of facilitating healthier food choices for people. More specifically, the primary aim of this project is to evaluate the effects of different varieties of quinoa on postprandial glucose tolerance and subjective appetite markers. The crossover, randomised dietary intervention study will be conducted in healthy adults.

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Key information

Conditions

Healthy Subjects Diet, Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University, dep of Food Technology, Engineering, and Nutrition

Lund, Välj..., 22100, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI of 20-28
  • age between 18-40 years
  • Healthy
  • consume a diet in accordance with Nordic Nutrition Recommendations

Exclusion criteria

  • not vegan
  • metabolic diseases (such as diabetes)
  • Gastro intestine tract problems or irritable bowel syndrome
  • known food allergies of intolerances
  • smoker
  • antibiotics should not have been consumed during the last 4 weeks
  • probiotics should not have been consumed during the last 4 weeks

Treatment and study plan

Bread products

Other

Four intervention products were included in the study. Three experimental breads (quinoa 1, quinoa 2, quinoa 3) were developed, and consisted of white wheat breads substituted with the differrent quinoa types. The reference product included was a white wheat bread without quinoa. All intervention products contain 50 g available starch.

Primary outcomes

  1. Glucose tolerance

    Time frame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

    Capillary blood glucose concentrations are measured repeatedly after test products consumed at breakfast. The postprandial incremental glucose area under the curve is used as a measure of glucose tolerance.

Secondary outcomes

  1. serum insulin

    Time frame: 3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

    Capillary serum insulin concentrations are measured repeatedly after test products consumed at breakfast. The postprandial incremental insulin area under the curve is used as a measure of insulin excretion needed for the control of the postprandial blood glucose increments.

  2. Subjective appetite sensations (hunger, satiety, and desire to eat)

    Time frame: 3 hours. Fasting (time =0 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes

    subjects will rank subjective appetite sensations repeatedly in the postprandial period after the test breakfasts, using 10 cm visual analogue scales.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Jun 8, 2023

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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