HypoglycemiaNCT01005342
Influence of Dietary Fiber-rich Meals on Gene Expression and Postprandial Glucose and Lipid Response
A study testing Oat bran, Spray-dried oat drink and Rye bran in people with Hypoglycemia and Hyperglycemia, run by Lund University at 1 site in Sweden.
Trial summary
The aim of this study is to Measure the effect on gene expression in leukocytes from a meal rich in oat bran Investigate the postprandial glucose, insulin and triglyceride responses after intake of meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal containing a mixture of these… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Hyperglycemia
- What is being tested?
- Oat bran, Spray-dried oat drink and Rye bran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to Jun 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18-30
Who cannot join
- pregnancy
- breastfeeding
- diabetes mellitus
- hepatitis B
- blood lipid lowering pharmaceuticals
- intolerance or allergy to cereals or sugar beet fiber
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Dietary Fibre-rich Meals on Gene Expression in Leukocytes and Postprandial Glucose and Lipid Response in Healthy Subjects
The aim of this study is to
- Measure the effect on gene expression in leukocytes from a meal rich in oat bran
- Investigate the postprandial glucose, insulin and triglyceride responses after intake of meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal containing a mixture of these three fibers
Read the detailed description
Dietary fiber has long been known to give beneficial health effects. Yet, the understanding of how fiber-rich meals regulate molecular events at a gene level is limited. Also, few studies have compared the effects of different fiber sources on postprandial responses and hardly any study the effects of fiber mixtures in the same meal, even though this is more similar to regular eating habits.
Healthy subjects will come to the study center after an overnight fast, to ingest breakfasts randomly enriched with different fiber. The meals contains either spray-dried oat drink, rye bran, sugar beet fiber a mixture of these three fibers, oat bran or no added fiber (control). All meals are adjusted to contain the same total amount of available carbohydrates and fat. Blood leukocytes for gene expression profiling were taken before and 2 h after consumption while blood samples for analysis of postprandial glucose, insulin and triglyceride levels were taken every 30 min during 3 h.
NuGO Affymetrix Human Genechip NuGO_Hs1a520180 are used for the microarray analysis and analysis is performed with linear mixed models and enrichment analysis to identify functional gene sets that responded to the specific oat bran effect.
- Conditions
- Hypoglycemia, Hyperglycemia
- Being tested
- Oat bran, Spray-dried oat drink, Rye bran, Sugar beet fiber, Mixture of fiber
- Keywords
- gene expression, oats, rye, sugar beet fiber, glucose, insulin, triglyceride, decreased postprandial glucose, decreased postprandial insulin, glycemic index
- Medical subject headings
- Hypoglycemia, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat branOther
Also called Oats, Beta-glucan
82 g oat bran was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12.6 g total fiber).
Spray-dried oat drinkOther
Also called Oats, Oat milk, Beta-glucan
62 g spray-dried oat drink was added to 250 ml blackcurrant beverage with pulp to give 2.7 g soluble fiber (3.3 g total fiber).
Rye branOther
Also called Rye, Arabinoxylan
31 g rye bran was added to 250 ml blackcurrant beverage with pulp to give 1.7 g soluble fiber (12 g total fiber).
Sugar beet fiberOther
Also called Sugar beet, Pectin
19 g sugar beet fiber was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12 g total fiber).
Mixture of fiberOther
38 g spray-dried oat drink, 30 g rye bran and 6 g sugar beet fiber were added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (18 g total fiber).
ControlOther
No fiber was added to control meal (250 g black-currant beverage)
| Study group | Role | What they receive |
|---|---|---|
| Mixture of fiber | Experimental | Single intake of a mixture of spray-dried oat drink, rye bran and sugar beet fiber Receives: Other: Mixture of fiber |
| Sugar beet fiber | Experimental | Single intake of sugar beet fiber Receives: Other: Sugar beet fiber |
| Rye bran | Experimental | Single intake of rye bran Receives: Other: Rye bran |
| Oat bran | Experimental | Single intake of oat bran Receives: Other: Oat bran |
| Spray-dried oat drink | Experimental | Single intake of spray-dried oat drink Receives: Other: Spray-dried oat drink |
| Control | Placebo comparator | Single intake of a meal with no added fiber Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed gene expression profile by fiber-rich meals
Measured: 2 h after meal intake
Secondary outcomes (1)
Lowering of postprandial glucose by fiber-rich meals
Measured: 0-180 min after meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startMay 2007
- Primary completionJun 2007
- Study completionJun 2007
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 HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova, Oatly AB, Lantmannen Food R&D, Danisco Sugar AB/Fibrex
- Investigators
- Gunilla Önning, Dr., Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005342
- Sponsor's protocol ID
- KCROS07
- Status last verified
- Oct 2009
- First submitted
- 29 Oct 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ulmius M, Johansson A, Onning G. The influence of dietary fibre source and gender on the postprandial glucose and lipid response in healthy subjects. Eur J Nutr. 2009 Oct;48(7):395-402. doi: 10.1007/s00394-009-0026-x. Epub 2009 May 5.
PubMed 19415409
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dietary Fibre-rich Meals on Gene Expression in Leukocytes and Postprandial Glucose and Lipid Response in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01005342
- Acronym / sponsor ID
- KCROS07
- Conditions
- Hypoglycemia, Hyperglycemia
- Keywords
- gene expression, oats, rye, sugar beet fiber, glucose, insulin, triglyceride, decreased postprandial glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Vinnova, Oatly AB, Lantmannen Food R&D, Danisco Sugar AB/Fibrex
- Study start
- May 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 30 Oct 2009 (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 aim of this study is to
- Measure the effect on gene expression in leukocytes from a meal rich in oat bran
- Investigate the postprandial glucose, insulin and triglyceride responses after intake of meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal containing a mixture of these three fibers
Detailed description
Dietary fiber has long been known to give beneficial health effects. Yet, the understanding of how fiber-rich meals regulate molecular events at a gene level is limited. Also, few studies have compared the effects of different fiber sources on postprandial responses and hardly any study the effects of fiber mixtures in the same meal, even though this is more similar to regular eating habits.
Healthy subjects will come to the study center after an overnight fast, to ingest breakfasts randomly enriched with different fiber. The meals contains either spray-dried oat drink, rye bran, sugar beet fiber a mixture of these three fibers, oat bran or no added fiber (control). All meals are adjusted to contain the same total amount of available carbohydrates and fat. Blood leukocytes for gene expression profiling were taken before and 2 h after consumption while blood samples for analysis of postprandial glucose, insulin and triglyceride levels were taken every 30 min during 3 h.
NuGO Affymetrix Human Genechip NuGO_Hs1a520180 are used for the microarray analysis and analysis is performed with linear mixed models and enrichment analysis to identify functional gene sets that responded to the specific oat bran effect.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mixture of fiber | Experimental | Other: Mixture of fiberSingle intake of a mixture of spray-dried oat drink, rye bran and sugar beet fiber |
| Sugar beet fiber | Experimental | Other: Sugar beet fiberSingle intake of sugar beet fiber |
| Rye bran | Experimental | Other: Rye branSingle intake of rye bran |
| Oat bran | Experimental | Other: Oat branSingle intake of oat bran |
| Spray-dried oat drink | Experimental | Other: Spray-dried oat drinkSingle intake of spray-dried oat drink |
| Control | Placebo comparator | Other: ControlSingle intake of a meal with no added fiber |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 18-30
Key exclusion criteria (6 listed)
- pregnancy
- breastfeeding
- diabetes mellitus
- hepatitis B
- blood lipid lowering pharmaceuticals
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 |
|---|---|---|
| Oat branAlso: Oats, Beta-glucan82 g oat bran was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12.6 g total fiber). | Other | Oat bran |
| Spray-dried oat drinkAlso: Oats, Oat milk, Beta-glucan62 g spray-dried oat drink was added to 250 ml blackcurrant beverage with pulp to give 2.7 g soluble fiber (3.3 g total fiber). | Other | Spray-dried oat drink |
| Rye branAlso: Rye, Arabinoxylan31 g rye bran was added to 250 ml blackcurrant beverage with pulp to give 1.7 g soluble fiber (12 g total fiber). | Other | Rye bran |
| Sugar beet fiberAlso: Sugar beet, Pectin19 g sugar beet fiber was added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (12 g total fiber). | Other | Sugar beet fiber |
| Mixture of fiber38 g spray-dried oat drink, 30 g rye bran and 6 g sugar beet fiber were added to 250 ml blackcurrant beverage with pulp to give 5 g soluble fiber (18 g total fiber). | Other | Mixture of fiber |
| ControlNo fiber was added to control meal (250 g black-currant beverage) | Other | Control |
Primary outcome
Changed gene expression profile by fiber-rich meals
Time frame: 2 h after meal intake
1 secondary outcome
Lowering of postprandial glucose by fiber-rich meals
Time frame: 0-180 min after meal intake
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 30 Oct 2009.
- Results publication: PubMed 19415409Ulmius M, Johansson A, Onning G. The influence of dietary fibre source and gender on the postprandial glucose and lipid response in healthy subjects. Eur J Nutr. 2009 Oct;48(7):395-402. doi: 10.1007/s00394-009-0026-x. Epub 2009 May 5.
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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.
Gunilla Önning, Dr. study director
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat bran, Spray-dried oat drink and Rye bran in people with Hypoglycemia and Hyperglycemia, run by Lund University 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 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: finished, as of the sponsor's last update on 30 Oct 2009. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Changed gene expression profile by fiber-rich meals (time frame: 2 h after meal intake). 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 NCT01005342, 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 30 Oct 2009.