Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Diet, Healthy
• Intervention / Treatment: Other: Bread products

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Nilsson, Assoc. Prof.; Phone Number: +46 46 2228343; Email: anne.nilsson@food.lth.se
• Study Contact Backup: Name: Juscelino Tovar, PhD; Phone Number: +46 46 222 86 27; Email: Juscelino.tovar@food.lth.se

Study Locations

• Sweden
  • Välj...
    • Lund, Välj..., Sweden, 22100
      • Lund University, dep of Food Technology, Engineering, and Nutrition
      • Contact: Juscelino Tovar, PhD; Phone Number: +46 46 222 86 27; Email: Juscelino.tovar@food.lth.se
      • Contact: Anne Nilsson, Assoc. prof.; Phone Number: +4646 2228343; Email: anne.nilsson@food.lth.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quinoa1; Quinoa bread type1.	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.
Experimental: Quinoa 2; Quinoa bread type 2	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.
Experimental: Quinoa 3; Quinoa bread type 3	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.
Sham Comparator: Reference; A white wheat bread	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Lund University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): June 3, 2023
• Study Completion (Actual): June 3, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Dnr: 2019-00980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No