Back to resultsEffects of Berries on Post-meal Blood Sugar (SOMA)
Primary Purpose
Blood Glucose, Postprandial, Blood Insulin, Postprandial, Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Berries
No berries
Sponsored by
About this trial
This is an interventional basic science trial for Blood Glucose, Postprandial focused on measuring Berries, Starch, Sucrose, Glucose, Insulin, Postprandial
Eligibility Criteria
Inclusion Criteria:
- BMI 20-28 kg/m2
- normal fasting plasma glucose
Exclusion Criteria:
- Smoking
- Diabetes or other chronic disease
- Antibiotic medication within the past 3 months
- Blood donation within the past month
Sites / Locations
- University of Eastern Finland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Berry meal
Reference meal
Arm Description
Carbohydrate meals with berries
Carbohydrate meals without berries
Outcomes
Primary Outcome Measures
Plasma glucose
Plasma insulin
Secondary Outcome Measures
Plasma free fatty acids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01580150
Brief Title
Effects of Berries on Post-meal Blood Sugar
Acronym
SOMA
Official Title
Effects of Berries on Postprandial Glycemic Responses to Sucrose and Starch
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marjukka Kolehmainen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.
Detailed Description
Berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. However, current evidence on the effects of berries on postprandial glycemic responses in humans is limited.
The purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in Finland and a reference meal without berries. The following combinations of carbohydrates and berries are studied:
Studies 1-2: white wheat bread (starch) is consumed with several berry species
Study 3: white wheat bread or rye bread is consumed with a mixture of berries
Study 4: sugar (sucrose) is consumed with berries and berry nectars
Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Glucose, Postprandial, Blood Insulin, Postprandial, Hyperglycemia
Keywords
Berries, Starch, Sucrose, Glucose, Insulin, Postprandial
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Berry meal
Arm Type
Experimental
Arm Description
Carbohydrate meals with berries
Arm Title
Reference meal
Arm Type
Active Comparator
Arm Description
Carbohydrate meals without berries
Intervention Type
Other
Intervention Name(s)
Berries
Intervention Description
Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).
Intervention Type
Other
Intervention Name(s)
No berries
Intervention Description
Meals containing starch (bread) or sucrose are consumed without berries.
Primary Outcome Measure Information:
Title
Plasma glucose
Time Frame
0, 15, 30, 45, 60, 90, 120 minutes post-meal
Title
Plasma insulin
Time Frame
0, 15, 30, 45, 60, 90, 120 minutes post-meal
Secondary Outcome Measure Information:
Title
Plasma free fatty acids
Time Frame
0, 15, 30, 45, 60, 90, 120 minutes post-meal
10. Eligibility
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 20-28 kg/m2
normal fasting plasma glucose
Exclusion Criteria:
Smoking
Diabetes or other chronic disease
Antibiotic medication within the past 3 months
Blood donation within the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riitta Törrönen, Dr
Organizational Affiliation
Senior Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
FI-70211
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23365108
Citation
Torronen R, Kolehmainen M, Sarkkinen E, Poutanen K, Mykkanen H, Niskanen L. Berries reduce postprandial insulin responses to wheat and rye breads in healthy women. J Nutr. 2013 Apr;143(4):430-6. doi: 10.3945/jn.112.169771. Epub 2013 Jan 30.
Results Reference
derived
PubMed Identifier
22854401
Citation
Torronen R, Kolehmainen M, Sarkkinen E, Mykkanen H, Niskanen L. Postprandial glucose, insulin, and free fatty acid responses to sucrose consumed with blackcurrants and lingonberries in healthy women. Am J Clin Nutr. 2012 Sep;96(3):527-33. doi: 10.3945/ajcn.112.042184. Epub 2012 Aug 1.
Results Reference
derived
Learn more about this trial
Effects of Berries on Post-meal Blood Sugar
We'll reach out to this number within 24 hrs