Overview

This trial is active, not recruiting.

Condition glucose metabolism
Treatment elsa 1-9
Sponsor National Institute for Health and Welfare, Finland
Start date January 2003
End date December 2008
Trial size 142 participants
Trial identifier NCT01477216, TUSU 182-5

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Experimental)
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.
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
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.
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
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.
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
To measure GI and II values for Finnish snack foods
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
To study the effects of berries on glycemic and insulinemic responses
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
To measure glycemic and insulinemic responses to low-carbohydrates foods
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
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.
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
To compare how methodological choices affect measured insulin values
elsa 1-9
Measuring GI and II values for Finnish foods
(Experimental)
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.
elsa 1-9
Measuring GI and II values for Finnish foods

Primary Outcomes

Measure
Glucose
time frame: 2 to 5 hours
Insulin
time frame: 2 to 5 hours
Free fatty acids
time frame: 2 to 5 hours
Triglyserides
time frame: 2 to 5 hours

Secondary Outcomes

Measure
IGF1
time frame: 2 to 5 hours
Satiety
time frame: 2 to 5 hours
IGF-BP1
time frame: 2 to 5 hours

Eligibility Criteria

Male or female participants from 20 years up to 72 years old.

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

Additional Information

Official title The Glycemic and Insulinemic Responses of the Finnish Foods: Measurement and Modification
Principal investigator Katja A Hätönen
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.