NCT01477216

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

5.9 years

First QC Date

October 4, 2011

Last Update Submit

November 18, 2011

Conditions

Glucose Metabolism

Keywords

Glycemic indexGlycemic responsesInsulin responsesInsulinemic indexCarbohydratesMethodologyGlucose metabolism

Outcome Measures

Primary Outcomes (4)

  • Glucose

    Area under the plasma concentration versus time curve (AUC) of food

    2 to 5 hours

  • Insulin

    Area under the plasma concentration versus time curve (AUC) of food

    2 to 5 hours

  • Free fatty acids

    Area under the plasma concentration versus time curve (AUC) of food

    2 to 5 hours

  • Triglyserides

    Area under the plasma concentration versus time curve (AUC) of food

    2 to 5 hours

Secondary Outcomes (3)

  • IGF1

    2 to 5 hours

  • Satiety

    2 to 5 hours

  • IGF-BP1

    2 to 5 hours

Study Arms (9)

Measuring method

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.

Other: ELSA 1-9

Mixed meals

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.

Other: ELSA 1-9

Coffee

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.

Other: ELSA 1-9

Snacks

EXPERIMENTAL

To measure GI and II values for Finnish snack foods

Other: ELSA 1-9

Berries

EXPERIMENTAL

To study the effects of berries on glycemic and insulinemic responses

Other: ELSA 1-9

GIs of low-carbs

EXPERIMENTAL

To measure glycemic and insulinemic responses to low-carbohydrates foods

Other: ELSA 1-9

Glucose metabolism and BMI

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.

Other: ELSA 1-9

Insulin measurement

EXPERIMENTAL

To compare how methodological choices affect measured insulin values

Other: ELSA 1-9

Alcohol

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.

Other: ELSA 1-9

Interventions

ELSA 1-9OTHER

Measuring GI and II values for Finnish foods

AlcoholBerriesCoffeeGIs of low-carbsGlucose metabolism and BMIInsulin measurementMeasuring methodMixed mealsSnacks

Eligibility Criteria

Age20 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22648716DERIVED

Study Officials

  • Liisa M Valsta, DSc

    National Institute for Health and Welfare, Helsinki, Finland

    STUDY DIRECTOR

  • Katja A Hätönen

    National Institute for Health and Welfare, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

November 22, 2011

Study Start

January 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2013

Last Updated

November 22, 2011

Record last verified: 2011-11