- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02876029
Food Design for Improved Day-long Glycaemic Regulation
August 26, 2016 updated by: Lund University
The Effect on Glucose Tolerance at a Second Meal Provided After Breakfast Meal Giving Late Increment in Postprandial Glycaemia
The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A study in healthy subjects using spaghetti as the test breakfast and a white wheat bread as the reference.
Glycaemia, insulinaemia, NEFA, TG and subjective appetite are studied up to the time of the lunch meal that is served 4h after breakfast.
After lunch the blood sampling continues for 2 hours.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 19-25
Exclusion Criteria:
- Smoker, Diabetes, Gluten intolerance, vegetarian
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Reference
White wheat bread
|
the reference product used
Other Names:
The test Product used
Other Names:
|
Other: Test product
Pasta
|
the reference product used
Other Names:
The test Product used
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose
Time Frame: 0-6 h
|
0-6 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-esterified fatty acids (NEFA)
Time Frame: 0-6 h
|
0-6 h
|
Triglycerides (TG)
Time Frame: 0-6 h
|
0-6 h
|
Appetite rating (Visual Analogue Scale)
Time Frame: 0-6 h
|
0-6 h
|
Insulin
Time Frame: 0-6 h
|
0-6 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Elin Östman, Ass prof, Food for Health Science Centre (Medicon Village) - Lund University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
August 18, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (Estimate)
August 23, 2016
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- AFC-GPSecMeal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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