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Determination of Glycemic and Insulinemic Indices (ELSA)

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ClinicalTrials.gov Identifier: NCT01477216
Recruitment Status : Unknown
Verified November 2011 by National Institute for Health and Welfare, Finland.
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland

Study Description
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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
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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
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01477216     History of Changes
Other Study ID Numbers: TUSU 182-5
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

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