Determination of Glycemic and Insulinemic Indices (ELSA)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2011 by National Institute for Health and Welfare, Finland.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

National Institute for Health and Welfare, Finland

ClinicalTrials.gov Identifier:

NCT01477216

First received: October 4, 2011

Last updated: November 18, 2011

Last verified: November 2011

History of Changes

Purpose

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	Intervention
Glucose Metabolism	Other: ELSA 1-9


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	The Glycemic and Insulinemic Responses of the Finnish Foods: Measurement and Modification

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:

Glucose [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) of food
Insulin [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) of food
Free fatty acids [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) of food
Triglyserides [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) of food

Secondary Outcome Measures:

IGF1 [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) of food
Satiety [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Satiety scores on the satiety scale
IGF-BP1 [ Time Frame: 2 to 5 hours ] [ Designated as safety issue: No ]
Area under the plasma concentration versus time curve (AUC) of food


Enrollment:	142
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2013
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	20 Years to 72 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01477216

Sponsors and Collaborators

National Institute for Health and Welfare, Finland

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hätönen KA, Virtamo J, Eriksson JG, Perälä MM, Sinkko HK, Leiviskä 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.


Responsible Party:	National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:	NCT01477216 History of Changes
Other Study ID Numbers:	TUSU 182-5
Study First Received:	October 4, 2011
Last Updated:	November 18, 2011
Health Authority:	Finland: National Advisory Board on Health Care Ethics

Keywords provided by National Institute for Health and Welfare, Finland:


Glycemic index Glycemic responses Insulin responses Insulinemic index	Carbohydrates Methodology Glucose metabolism

Additional relevant MeSH terms:


Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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