Determination of Glycemic and Insulinemic Indices (ELSA)

• ClinicalTrials.gov Identifier: NCT01477216
• Recruitment Status: Unknown
• First Posted: November 22, 2011
• Last Update Posted: November 22, 2011
• Sponsor: Finnish Institute for Health and Welfare
• Information provided by (Responsible Party): Finnish Institute for Health and Welfare

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: January 2003
• Actual Primary Completion Date: December 2008
• Estimated Study Completion Date: December 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 :

1. Glucose [ Time Frame: 2 to 5 hours ]
   Area under the plasma concentration versus time curve (AUC) of food
2. Insulin [ Time Frame: 2 to 5 hours ]
   Area under the plasma concentration versus time curve (AUC) of food
3. Free fatty acids [ Time Frame: 2 to 5 hours ]
   Area under the plasma concentration versus time curve (AUC) of food
4. Triglyserides [ Time Frame: 2 to 5 hours ]
   Area under the plasma concentration versus time curve (AUC) of food

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 72 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

More Information

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

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.

• Responsible Party: Finnish Institute for Health and Welfare
• ClinicalTrials.gov Identifier: NCT01477216
• Other Study ID Numbers: TUSU 182-5
• First Posted: November 22, 2011
• Last Update Posted: November 22, 2011
• Last Verified: November 2011

Keywords provided by Finnish Institute for Health and Welfare:

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