Evaluation of Potentially Bioactive Foods With Respect to Cardiometabolic Test Variables
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2023
CompletedStudy Start
First participant enrolled
April 15, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2023
CompletedJune 8, 2023
June 1, 2023
2 months
April 6, 2023
June 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
serum insulin
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)
3 hours. Fasting (time =0 minutes), 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Study Arms (4)
Quinoa1
EXPERIMENTALQuinoa bread type1.
Quinoa 2
EXPERIMENTALQuinoa bread type 2
Quinoa 3
EXPERIMENTALQuinoa bread type 3
Reference
SHAM COMPARATORA white wheat bread
Interventions
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.
Eligibility Criteria
You may qualify if:
- BMI of 20-28
- age between 18-40 years
- Healthy
- consume a diet in accordance with Nordic Nutrition Recommendations
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Lund University, dep of Food Technology, Engineering, and Nutrition
Lund, Välj..., 22100, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 21, 2023
Study Start
April 15, 2023
Primary Completion
June 3, 2023
Study Completion
June 3, 2023
Last Updated
June 8, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share