HealthyNCT00779298
Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects
An observational study of Healthy, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term "whole grain" is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All subjects were recruited from the population in a southern county of Sweden.
Who may be able to join
- without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus
Who cannot join
- with symptoms or prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Medicine, Malmö University Hospital,
Malmö, Skåne County, 205 02
About this study
Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term "whole grain" is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large proportion of whole cereal grains is intact. The aim of this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in healthy subjects.
Read the detailed description
Ten healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were assessed by using a blinded crossover trial. The subjects were examined regarding blood glucose levels and GER after ingestion of 150g WWB or RWMB on two different occasions after an overnight fast. GER was measured using a standardized real time ultrasonography. GER was calculated as a percentage change in antral cross sectional area 15 and 90 minutes after the finished meal with WWB and RWMB. Finger-prick capillary samples were collected before and 40, 60, and 90 min after the start of the meal to measure blood glucose levels.
- Conditions
- Healthy
- Keywords
- rye whole-meal bread, white-wheat bread, gastric emptying rate, postprandial glucose response, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (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 HealthyStudies 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
- Observational
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779298
- Sponsor's protocol ID
- Dnr 709/2004
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hlebowicz J, Jonsson JM, Lindstedt S, Bjorgell O, Darwich G, Almer LO. Effect of commercial rye whole-meal bread on postprandial blood glucose and gastric emptying in healthy subjects. Nutr J. 2009 Jun 16;8:26. doi: 10.1186/1475-2891-8-26.
PubMed 19531257
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Commercial Rye Whole-Meal Bread on Postprandial Blood Glucose and Gastric Emptying in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00779298
- Acronym / sponsor ID
- Dnr 709/2004
- Conditions
- Healthy
- Keywords
- rye whole-meal bread, white-wheat bread, gastric emptying rate, postprandial glucose response, healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- First posted
- 24 Oct 2008 (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.
Increased intake of dietary fibre and whole grains is related to reduced risk of developing diabetes. The term "whole grain" is often used for whole-meal products in which the structure of the cereal grain is destroyed in the flour containing the original dietary fiber, but also for cereal products in which a large proportion of whole cereal grains is intact. The aim of this study was to evaluate the effect of commercial rye whole-meal bread (RWMB) compared to white-wheat bread (WWB) on gastric emptying rate (GER), postprandial glucose response in healthy subjects.
Detailed description
Ten healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were assessed by using a blinded crossover trial. The subjects were examined regarding blood glucose levels and GER after ingestion of 150g WWB or RWMB on two different occasions after an overnight fast. GER was measured using a standardized real time ultrasonography. GER was calculated as a percentage change in antral cross sectional area 15 and 90 minutes after the finished meal with WWB and RWMB. Finger-prick capillary samples were collected before and 40, 60, and 90 min after the start of the meal to measure blood glucose levels.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –Healthy subjects, without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects were recruited from the population in a southern county of Sweden.
Key inclusion criteria (1 listed)
- without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus
Key exclusion criteria (1 listed)
- with symptoms or prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
- Derived from this study: PubMed 19531257Hlebowicz J, Jonsson JM, Lindstedt S, Bjorgell O, Darwich G, Almer LO. Effect of commercial rye whole-meal bread on postprandial blood glucose and gastric emptying in healthy subjects. Nutr J. 2009 Jun 16;8:26. doi: 10.1186/1475-2891-8-26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Lund University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00779298, 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 24 Oct 2008.