Blood Glucose ConcentrationNCT02400411
The Glycemic and Insulinemic Responses Elicited by Meals Containing Whole Grain Rye Bread or White Wheat Bread
A study testing Wheat bread, margarine and ham in people with Blood Glucose Concentration, run by University of Helsinki.
Trial summary
This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Concentration
- What is being tested?
- Wheat bread, margarine and ham
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Oct 2015
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- BMI 18-27 kg/m2
Who cannot join
- pregnant or breastfeeding
- diabetes, gastrointestinal disease
- regular use of medication
- strict vegetarian or vegan diet
- food allergy
- recent blood donation
About this study
Official title: The Effects of Margarine and Ham or Vegetable Soup on the on the Glycemic and Insulinemic Responses Elicited by Whole Grain Rye Bread or White Wheat Bread
This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations are monitored from finger prick blood samples collected before the meal and at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30 and 60 min.
- Conditions
- Blood Glucose Concentration
- Being tested
- Wheat bread, margarine, ham, soup, rye bread
- Keywords
- Carbohydrate, Glycemic response, insulin, whole grain, meal
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat breadOther
margarineOther
hamOther
soupOther
rye breadOther
| Study group | Role | What they receive |
|---|---|---|
| Wheat bread | Experimental | Bread-based meal Receives: Other: Wheat bread |
| Wheat bread with margarine and ham | Experimental | Bread-based meal Receives: Other: Wheat bread; Other: margarine; Other: ham |
| Wheat bread with margarine, ham and soup | Experimental | Bread-based meal Receives: Other: Wheat bread; Other: margarine; Other: ham; Other: soup |
| Rye bread | Experimental | Bread-based meal Receives: Other: rye bread |
| Rye bread with margarine and ham | Experimental | Bread-based meal Receives: Other: margarine; Other: ham; Other: rye bread |
| Rye bread with margarine, ham and soup | Experimental | Bread-based meal Receives: Other: margarine; Other: ham; Other: soup; Other: rye bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentration
Measured: 120 min
Secondary outcomes (1)
Serum insulin concentration
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose ConcentrationStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Fazer Group
- Responsible party
- Principal investigator, Mikael Fogelholm, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400411
- Sponsor's protocol ID
- HY_RAV_Breadmeal
- Status last verified
- Sep 2015
- First submitted
- 17 Mar 2015
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Margarine and Ham or Vegetable Soup on the on the Glycemic and Insulinemic Responses Elicited by Whole Grain Rye Bread or White Wheat Bread
- ClinicalTrials.gov ID
- NCT02400411
- Acronym / sponsor ID
- HY_RAV_Breadmeal
- Conditions
- Blood Glucose Concentration
- Keywords
- Carbohydrate, Glycemic response, insulin, whole grain, meal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Fazer Group
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (estimated)
- First posted
- 27 Mar 2015 (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.
This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations are monitored from finger prick blood samples collected before the meal and at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30 and 60 min.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Wheat bread | Experimental | Other: Wheat breadBread-based meal |
| Wheat bread with margarine and ham | Experimental | Other: Wheat bread, Other: margarine, Other: hamBread-based meal |
| Wheat bread with margarine, ham and soup | Experimental | Other: Wheat bread, Other: margarine, Other: ham, Other: soupBread-based meal |
| Rye bread | Experimental | Other: rye breadBread-based meal |
| Rye bread with margarine and ham | Experimental | Other: margarine, Other: ham, Other: rye breadBread-based meal |
| Rye bread with margarine, ham and soup | Experimental | Other: margarine, Other: ham, Other: soup, Other: rye breadBread-based meal |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female
- BMI 18-27 kg/m2
Key exclusion criteria (6 listed)
- pregnant or breastfeeding
- diabetes, gastrointestinal disease
- regular use of medication
- strict vegetarian or vegan diet
- food allergy
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 |
|---|---|---|
| Wheat bread | Other | Wheat bread, Wheat bread with margarine and ham, Wheat bread with margarine, ham and soup |
| margarine | Other | Rye bread with margarine and ham, Rye bread with margarine, ham and soup, Wheat bread with margarine and ham, Wheat bread with margarine, ham and soup |
| ham | Other | Rye bread with margarine and ham, Rye bread with margarine, ham and soup, Wheat bread with margarine and ham, Wheat bread with margarine, ham and soup |
| soup | Other | Rye bread with margarine, ham and soup, Wheat bread with margarine, ham and soup |
| rye bread | Other | Rye bread, Rye bread with margarine and ham, Rye bread with margarine, ham and soup |
Primary outcome
Blood glucose concentration
Time frame: 120 min
1 secondary outcome
Serum insulin concentration
Time frame: 60 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat bread, margarine and ham in people with Blood Glucose Concentration, run by University of Helsinki.
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 2 inclusion and 6 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 4 Sep 2015. 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?
Blood glucose concentration (time frame: 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.