Clinical trial NCT01477216: Determination of Glycemic and Insulinemic Indices
Official title: The Glycemic and Insulinemic Responses of the Finnish Foods: Measurement and Modification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism
Keywords: Glycemic index
Glycemic responses
Insulin responses
Insulinemic index
Carbohydrates
Methodology
Glucose metabolism
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
First posted: 2011-11-22
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Glucose
timeFrame: 2 to 5 hours
measure: Insulin
timeFrame: 2 to 5 hours
measure: Free fatty acids
timeFrame: 2 to 5 hours
measure: Triglyserides
timeFrame: 2 to 5 hours
Secondary outcomes:
measure: IGF1
timeFrame: 2 to 5 hours
measure: Satiety
timeFrame: 2 to 5 hours
measure: IGF-BP1
timeFrame: 2 to 5 hours
Other outcomes:
Locations:
Study officials:
affiliation: National Institute for Health and Welfare, Helsinki, Finland
name: Liisa M Valsta, DSc
role: STUDY_DIRECTOR
affiliation: National Institute for Health and Welfare, Helsinki, Finland
name: Katja A Hätönen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.