ELSA: Determination of Glycemic and Insulinemic Indices

Sponsor

Finnish Institute for Health and Welfare (Other)

Overall Status

Unknown status

CT.gov ID

NCT01477216

Collaborator

(none)

142

Enrollment

Arms

131

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism	Other: ELSA 1-9	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Glucose [2 to 5 hours]
Area under the plasma concentration versus time curve (AUC) of food
Insulin [2 to 5 hours]
Area under the plasma concentration versus time curve (AUC) of food
Free fatty acids [2 to 5 hours]
Area under the plasma concentration versus time curve (AUC) of food
Triglyserides [2 to 5 hours]
Area under the plasma concentration versus time curve (AUC) of food

Secondary Outcome Measures

IGF1 [2 to 5 hours]
Area under the plasma concentration versus time curve (AUC) of food
Satiety [2 to 5 hours]
Satiety scores on the satiety scale
IGF-BP1 [2 to 5 hours]
Area under the plasma concentration versus time curve (AUC) of food

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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