- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04831268
Effects of Traditional Greek Meals on Glycemic Responses
Effects of Traditional Greek Meals: Lentils With Lupino, Trahanas With Tomato Sauce and Halva With Currants on Glycemic Responses: Randomized Clinical Trial in Healthy Humans
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Attica
-
Athens, Attica, Greece, 11855
- Agricultural University of Athens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy
- non-smoking
- non-diabetic men and women
- normal body mass index (BMI; between 18.5 and 25 kg/m2)
Exclusion Criteria:
- severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
- gastrointestinal disorders
- pregnancy
- lactation
- competitive sports
- alcohol
- drug dependency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glucose as reference food
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
|
|
Experimental: Lentils and lupins mixed meal
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
|
|
Experimental: Trahanas with tomato sauce mixed meal
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
|
|
Experimental: Halva with currants mixed meal
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first bite of food or drink. |
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min.
Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capillary blood glucose responses
Time Frame: 2 hours
|
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite ratings
Time Frame: 2 hours
|
Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120 min.
The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g hunger, satiety, desire to eat etc.
|
2 hours
|
|
Blood pressure
Time Frame: 2 hours
|
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of three mixed meals
|
2 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRBD 24 04/04/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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