Glucose MetabolismELSANCT01477216

Determination of Glycemic and Insulinemic Indices

A study testing ELSA 1-9 in people with Glucose Metabolism, run by Finnish Institute for Health and Welfare.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 72 yearsHealthy volunteers can take part
Conditions the study is for: Glucose Metabolism
What is being tested?: ELSA 1-9
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: No sites listed yet
Study dates: Jan 2003to Dec 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 72 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

Breastfeeding
History of polycystic ovary syndrome
History of gestational diabetes

About this study

Official title: The Glycemic and Insulinemic Responses of the Finnish Foods: Measurement and Modification

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

Conditions: Glucose Metabolism
Being tested: ELSA 1-9
Keywords: Glycemic index, Glycemic responses, Insulin responses, Insulinemic index, Carbohydrates, Methodology, Glucose metabolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ELSA 1-9Other
Measuring GI and II values for Finnish foods

Study groups in NCT01477216
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: ELSA 1-9
Snacks	Experimental	To measure GI and II values for Finnish snack foods Receives: Other: ELSA 1-9
Berries	Experimental	To study the effects of berries on glycemic and insulinemic responses Receives: Other: ELSA 1-9
GIs of low-carbs	Experimental	To measure glycemic and insulinemic responses to low-carbohydrates foods Receives: 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. Receives: Other: ELSA 1-9
Insulin measurement	Experimental	To compare how methodological choices affect measured insulin values Receives: 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. Receives: Other: ELSA 1-9

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose
Area under the plasma concentration versus time curve (AUC) of food
Measured: 2 to 5 hours
Insulin
Area under the plasma concentration versus time curve (AUC) of food
Measured: 2 to 5 hours
Free fatty acids
Area under the plasma concentration versus time curve (AUC) of food
Measured: 2 to 5 hours
Triglyserides
Area under the plasma concentration versus time curve (AUC) of food
Measured: 2 to 5 hours

Secondary outcomes (3)

IGF1
Area under the plasma concentration versus time curve (AUC) of food
Measured: 2 to 5 hours
Satiety
Satiety scores on the satiety scale
Measured: 2 to 5 hours
IGF-BP1
Area under the plasma concentration versus time curve (AUC) of food
Measured: 2 to 5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Dec 2013

First posted22 Nov 2011 (estimated)
Study startJan 2003
Primary completionDec 2008
Study completionDec 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glucose MetabolismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01477216
Sponsor's protocol ID: TUSU 182-5
Acronym: ELSA
Status last verified: Nov 2011
First submitted: 4 Oct 2011
Last updated: 22 Nov 2011
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 22648716

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight

All Glucose Metabolism trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Glycemic and Insulinemic Responses of the Finnish Foods: Measurement and Modification
ClinicalTrials.gov ID: NCT01477216
Acronym / sponsor ID: ELSA / TUSU 182-5
Conditions: Glucose Metabolism
Keywords: Glycemic index, Glycemic responses, Insulin responses, Insulinemic index, Carbohydrates, Methodology, Glucose metabolism
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 142 participants (actual)
Lead sponsor: Finnish Institute for Health and WelfareOther government
Study start: Jan 2003
Primary completion: Dec 2008 (actual)
Study completion: Dec 2013 (estimated)
First posted: 22 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 9

Arm	Type	Receives
Measuring method	Experimental	Other: ELSA 1-9To 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.
Mixed meals	Experimental	Other: ELSA 1-9To 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.
Coffee	Experimental	Other: ELSA 1-9To 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.
Snacks	Experimental	Other: ELSA 1-9To measure GI and II values for Finnish snack foods
Berries	Experimental	Other: ELSA 1-9To study the effects of berries on glycemic and insulinemic responses
GIs of low-carbs	Experimental	Other: ELSA 1-9To measure glycemic and insulinemic responses to low-carbohydrates foods
Glucose metabolism and BMI	Experimental	Other: ELSA 1-9To 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.
Insulin measurement	Experimental	Other: ELSA 1-9To compare how methodological choices affect measured insulin values
Alcohol	Experimental	Other: ELSA 1-9To 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.

Who may qualify

Ages: 20 to 72 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ELSA 1-9Measuring GI and II values for Finnish foods	Other	Alcohol, Berries, Coffee, GIs of low-carbs, Glucose metabolism and BMI, Insulin measurement, Measuring method, Mixed meals, Snacks

Primary outcome

Glucose
Time frame: 2 to 5 hours
Area under the plasma concentration versus time curve (AUC) of food
Insulin
Time frame: 2 to 5 hours
Area under the plasma concentration versus time curve (AUC) of food
Free fatty acids
Time frame: 2 to 5 hours
Area under the plasma concentration versus time curve (AUC) of food
Triglyserides
Time frame: 2 to 5 hours
Area under the plasma concentration versus time curve (AUC) of food

3 secondary outcomes

IGF1
Time frame: 2 to 5 hours
Satiety
Time frame: 2 to 5 hours
IGF-BP1
Time frame: 2 to 5 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
Derived from this study: PubMed 22648716Hatonen 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.

Related trials for Glucose Metabolism

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Liisa M Valsta, DSc study director

National Institute for Health and Welfare, Helsinki, Finland

Katja A Hätönen principal investigator

National Institute for Health and Welfare, Helsinki, Finland

Questions about this trial

What is this clinical trial studying?

A study testing ELSA 1-9 in people with Glucose Metabolism, run by Finnish Institute for Health and Welfare.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose (time frame: 2 to 5 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01477216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.