Prebiotic Effects on Glucose Tolerance
Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora
1 other identifier
interventional
19
1 country
1
Brief Summary
The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.
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 Oct 2019
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
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2020
CompletedJune 25, 2020
June 1, 2020
8 months
May 8, 2019
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose tolerance
The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast.
3 hours
Secondary Outcomes (3)
Subjective appetite variables
3 hours
Mood parameters
3 hours
Breath hydrogen
3 hours
Study Arms (5)
Reference product
SHAM COMPARATORCommercial cereals and a commercial yogurt
Test product A
EXPERIMENTALSpecific designed cereals A and yogurt
Test product B
EXPERIMENTALSpecific designed cereals B and yogurt
Test product C
EXPERIMENTALSpecific designed cereals C and yogurt
Test product D
EXPERIMENTALSpecific designed cereals D and yogurt
Interventions
The cereal products are made from common Swedish cereals.
Eligibility Criteria
You may qualify if:
- BMI 18.5 - 25 kg/m2
- age 20-40 years
- normal diet
- healthy
You may not qualify if:
- fasting blood glucose \>6.1
- diagnosed or known disease
- known gastrointestinal disorder
- food allergies or intolerance
- special diet regiments
- smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Lund University, Food Technology, Engineering and Nutrition
Lund, 22100, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Nilsson, associate professor
Lund University
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, senior lecturer
Study Record Dates
First Submitted
May 8, 2019
First Posted
May 9, 2019
Study Start
October 15, 2019
Primary Completion
June 15, 2020
Study Completion
June 24, 2020
Last Updated
June 25, 2020
Record last verified: 2020-06