The Effect of Black Currant on Postprandial Glucose Metabolism (MAQUA)
Primary Purpose
Postprandial Hyperglycemia, Prediabetic State
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Black currant
Black currant-quinoa product
Quinoa base
Sponsored by
About this trial
This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring berries, black currant, glucose, glycemia, quinoa
Eligibility Criteria
Inclusion Criteria:
- age: 25-65 years
- BMI: 20-28 kg/m2
- Perceived health status: Good
Exclusion Criteria:
- fasting glucose: > 7.0 mmol/l
- LDL-cholesterol: > 3.0 mmol/l
- total cholesterol: > 6.5 mmol/l
- blood pressure : > 160/100 mmHg
- weight change of > 5% during previous 6 months or active weightreduction
- no serious chronic diseases
- one exception of the exclusion criteria maybe accepted after the MD consideration
Sites / Locations
- University of Eastern Finland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
Black currant puree
Black currant-quinoa product
Quinoa base
Liquid with glucose, fructose and sucrose
Arm Description
Black currant puree
Black currant-quinoa product
Quinoa base is used for the black currant-quinoa product.
Liquid with glucose, fructose and sucrose
Outcomes
Primary Outcome Measures
Glucose concentration
Glucose concentration after meal
Insulin concentration
Insulin concentration after meal
Secondary Outcome Measures
Full Information
NCT ID
NCT04150926
First Posted
November 1, 2019
Last Updated
September 3, 2020
Sponsor
University of Eastern Finland
Collaborators
Savonia University of Applied Sciences, Regional Development Company SavoGrow
1. Study Identification
Unique Protocol Identification Number
NCT04150926
Brief Title
The Effect of Black Currant on Postprandial Glucose Metabolism
Acronym
MAQUA
Official Title
The Effect of Black Currant on Postprandial Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Eastern Finland
Collaborators
Savonia University of Applied Sciences, Regional Development Company SavoGrow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest.
Detailed Description
The study examines the effect of black currant on glucose and insulin concentrations after a meal.
Healthy (n= 30) volunteers are recruited to participate in four consecutive visits in the research laboratory, when four meals are served in randomised order. Meals are: black currant puree, black currant and quinoa based snack, quinoa base and liquid containing glucose, fructose and sucrose. The meals contain the same amount of carbohydrates.
In addition to glucose and insulin concentration, cytokine and free fatty acid concentrations are measured after each meal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia, Prediabetic State
Keywords
berries, black currant, glucose, glycemia, quinoa
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Meal studies in randomised order
Masking
Participant
Masking Description
Products are visibly differing from each other.
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Black currant puree
Arm Type
Experimental
Arm Description
Black currant puree
Arm Title
Black currant-quinoa product
Arm Type
Active Comparator
Arm Description
Black currant-quinoa product
Arm Title
Quinoa base
Arm Type
Active Comparator
Arm Description
Quinoa base is used for the black currant-quinoa product.
Arm Title
Liquid with glucose, fructose and sucrose
Arm Type
No Intervention
Arm Description
Liquid with glucose, fructose and sucrose
Intervention Type
Other
Intervention Name(s)
Black currant
Intervention Description
The effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose
Experimental: Black currant and quinoa product
Active Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base
Intervention Type
Other
Intervention Name(s)
Black currant-quinoa product
Intervention Description
The effect of black currant puree will be compared with black currant-quinoa product
Intervention Type
Other
Intervention Name(s)
Quinoa base
Intervention Description
The effect of black currant puree will be compared with quinoa base
Primary Outcome Measure Information:
Title
Glucose concentration
Description
Glucose concentration after meal
Time Frame
0 minutes until 180 minutes
Title
Insulin concentration
Description
Insulin concentration after meal
Time Frame
0 minutes until 180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age: 25-65 years
BMI: 20-28 kg/m2
Perceived health status: Good
Exclusion Criteria:
fasting glucose: > 7.0 mmol/l
LDL-cholesterol: > 3.0 mmol/l
total cholesterol: > 6.5 mmol/l
blood pressure : > 160/100 mmHg
weight change of > 5% during previous 6 months or active weightreduction
no serious chronic diseases
one exception of the exclusion criteria maybe accepted after the MD consideration
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anonymised data maybe shared in the future.
Learn more about this trial
The Effect of Black Currant on Postprandial Glucose Metabolism
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