Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824195
• Other study ID #: Dnr: 2019-00980
• Status: Completed
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: June 3, 2023

Study information

• Verified date: June 2023
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 3, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Healthy Subjects

Intervention

Other:
• Bread products
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.

Locations

Country	Name	City	State
Sweden	Lund University, dep of Food Technology, Engineering, and Nutrition	Lund	Välj...

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance	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.	3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary	serum insulin	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.	3 hours. Fasting (time =0 minutes), 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Secondary	Subjective appetite sensations (hunger, satiety, and desire to eat)	subjects will rank subjective appetite sensations repeatedly in the postprandial period after the test breakfasts, using 10 cm visual analogue scales.	3 hours. Fasting (time =0 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes