Determination of Glycemic and Insulinemic Indices (ELSA)

The Glycemic and Insulinemic Responses of the Finnish Foods: Measurement and Modification

The aim of this study to investigate methodological aspects that may affect glycemic index (GI) and insulinemic (II) values. In addition, we will measure GI and II values for typical Finnish carbohydrate-rich foods and provide a database of GIs for Finnish foods.

The specific aims of this study are:

• to compare glycemic responses and GIs analyzed from capillary and venous blood to compare glucose against white bread as the reference food, and to study the effect of number of reference tests on GI values. For each setting of the tested parameters, we determined the glycemic indices of rye bread, oatmeal porridge and instant mashed potato
• to examine the glycaemic and insulinaemic responses of a mashed potato-based meal when a high fat food (rapeseed oil) or a high protein food (chicken breast) or fat, protein and salad together were added to the meal. Furthermore, we studied how the predicted and measured GI values of the mixed meal differed from each other.
• to examine the effects of two different coffee portions with glucose and caffeine-containing soft drinks on postprandial glucose and insulin responses. Further objectives were to study how coffee and different accompaniments affect glucose and insulin responses.
• to measure GI values for typical Finnish foods
• to study the effects of berries on glycemic and insulinemic responses
• to examine the effects of overweight and glucose tolerance on the glucose, insulin and lipid responses to an HGI meal and an LGI meal.Furthermore, the second aim was to study the effect of BMI and glucose tolerance on the GI measured.
• to compare methodological choices in insulin measurement
• to investigate the effect of alcohol on postprandial glucose and insulin responses, and to determine glycemic and insulinemic indices values for beer and non-alcoholic beer

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism
• Intervention / Treatment: Other: ELSA 1-9

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• For Studies 1-9 a total of 12 to 24 volunteers per study with a normal glucose tolerance based upon a 2 h 75g oral glucose tolerance test (OGTT).
• For Study 7 a total of 24 volunteers with impaired glucose tolerance based on an OGTT.
• For Studies 1-6 and 8-9 with an age of 20 to 60 and with a BMI of 18 to 30 kg/m2.
• For Study 7 an age of 62 to 72 and with a BMI of 20 to 35 kg/m2.

Exclusion Criteria:

• First-degree family history of diabetes
• An active gastrointestinal or metabolic disease
• For Studies 1-6 and 8-9 chronic medication (oral contraceptives were allowed)
• For Study 7 regular medication that would have affect glucose and lipid metabolism
• Smoking
• Pregnancy
• Breastfeeding
• History of polycystic ovary syndrome
• History of gestational diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measuring method; To compare glycemic responses and GI values from capillary and venous blood and to compare glucose solution with white bread as the reference food and to study the effect of the number of reference tests on GI values.	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Mixed meals; To examine the glycaemic and insulinaemic responses of a mashed potato-based meal when a high fat food (rapeseed oil) or a high protein food (chicken breast) or fat, protein and salad together were added to the meal. Furthermore, we studied how the predicted and measured GI values of the mixed meal differed from each other.	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Coffee; To examine the effects of two different coffee portions with glucose and caffeine-containing soft drinks on postprandial glucose and insulin responses. Further objectives were to study how coffee and different accompaniments affect glucose and insulin responses.	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Snacks; To measure GI and II values for Finnish snack foods	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Berries; To study the effects of berries on glycemic and insulinemic responses	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: GIs of low-carbs; To measure glycemic and insulinemic responses to low-carbohydrates foods	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Glucose metabolism and BMI; To examine the effects of overweight and glucose tolerance on the glucose, insulin and lipid responses to an HGI meal and an LGI meal. Furthermore, the second aim was to study the effect of BMI and glucose tolerance on the GI measured.	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Insulin measurement; To compare how methodological choices affect measured insulin values	Other: ELSA 1-9; Measuring GI and II values for Finnish foods
Experimental: Alcohol; To investigate the effect of alcohol on postprandial glucose and insulin responses, and to determine glycemic and insulinemic indices values for beer and non-alcoholic beer.	Other: ELSA 1-9; Measuring GI and II values for Finnish foods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Area under the plasma concentration versus time curve (AUC) of food	2 to 5 hours
Insulin	Area under the plasma concentration versus time curve (AUC) of food	2 to 5 hours
Free fatty acids	Area under the plasma concentration versus time curve (AUC) of food	2 to 5 hours
Triglyserides	Area under the plasma concentration versus time curve (AUC) of food	2 to 5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGF1	Area under the plasma concentration versus time curve (AUC) of food	2 to 5 hours
Satiety	Satiety scores on the satiety scale	2 to 5 hours
IGF-BP1	Area under the plasma concentration versus time curve (AUC) of food	2 to 5 hours

Collaborators and Investigators

• Sponsor: Finnish Institute for Health and Welfare
• Investigators: Study Director: Liisa M Valsta, DSc, National Institute for Health and Welfare, Helsinki, Finland; Principal Investigator: Katja A Hätönen, National Institute for Health and Welfare, Helsinki, Finland

Publications and helpful links

General Publications

• Hatonen KA, Virtamo J, Eriksson JG, Perala MM, Sinkko HK, Leiviska J, Valsta LM. Modifying effects of alcohol on the postprandial glucose and insulin responses in healthy subjects. Am J Clin Nutr. 2012 Jul;96(1):44-9. doi: 10.3945/ajcn.111.031682. Epub 2012 May 30.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): December 1, 2008
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 18, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Glycemic index; Carbohydrates; Glucose metabolism; Methodology; Insulinemic index; Glycemic responses; Insulin responses
• Other Study ID Numbers: TUSU 182-5