Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables

• Sponsor: Lund University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05824195
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 1.9
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Diet, Healthy	Other: Bread products	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic- and Cognitive Test Variables
• Anticipated Study Start Date: May 2, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Glucose tolerance [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 Outcome Measures

1. serum insulin [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lund University, dep of Food Technology, Engineering, and Nutrition	Lund	Välj...	Sweden	22100

Sponsors and Collaborators

• Lund University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Nilsson, Associate professor, Lund University
• ClinicalTrials.gov Identifier: NCT05824195
• Other Study ID Numbers: Dnr: 2019-00980
• First Posted: Apr 21, 2023
• Last Update Posted: Apr 21, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 21, 2023