Metabolic SyndromeEarly Phase 1NCT01718431
Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition
A Early Phase 1 study testing test meal and reference meal in people with Metabolic Syndrome, run by Lund University at 1 site in Sweden.
Trial summary
This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- test meal and reference meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Mar 2013
- Phase
- Early Phase 1
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 19-28 kg/m2
Who cannot join
- gastrointestinal diseases
- metabolic disorders
- tobacco/snuff user
- antibiotic/probiotic treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Applied Nutrition and Food Chemistry, Lund University
Lund, SE-221 00
About this study
Official title: Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.
This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.
- Conditions
- Metabolic Syndrome
- Being tested
- test meal, reference meal
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test mealOther
reference mealOther
| Study group | Role | What they receive |
|---|---|---|
| indigestible carbohydrates | Experimental | test meal: indigestible carbohydrates Receives: Other: test meal |
| reference | Experimental | reference meal: no indigestible carbohydrates Receives: Other: reference meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of the test meal
The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.
Measured: Post-prandially after breakfast, 0-150 min
Secondary outcomes (2)
Cognitive performance
The cognitive performance of the test subjects is measured to investigate work memory and specific attention.
Measured: Post-prandially after breakfast, 0-210 min
Subjective satiety
The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.
Measured: post-prandially after breakfast, 0-150 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
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 Metabolic SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elin Johansson, Lund University
- Investigators
- Anne Nilsson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718431
- Sponsor's protocol ID
- Dnr2010/457 - 3day
- Status last verified
- May 2013
- First submitted
- 9 Oct 2012
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.
PubMed 26259632
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.
- ClinicalTrials.gov ID
- NCT01718431
- Acronym / sponsor ID
- Dnr2010/457 - 3day
- Conditions
- Metabolic Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Oct 2012 (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 study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indigestible carbohydrates | Experimental | Other: test mealtest meal: indigestible carbohydrates |
| reference | Experimental | Other: reference mealreference meal: no indigestible carbohydrates |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 19-28 kg/m2
Key exclusion criteria (4 listed)
- gastrointestinal diseases
- metabolic disorders
- tobacco/snuff user
- antibiotic/probiotic treatment
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 |
|---|---|---|
| test meal | Other | indigestible carbohydrates |
| reference meal | Other | reference |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of the test meal
Time frame: Post-prandially after breakfast, 0-150 min
The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.
2 secondary outcomes
Cognitive performance
Time frame: Post-prandially after breakfast, 0-210 min
Subjective satiety
Time frame: post-prandially after breakfast, 0-150 min
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 8 May 2013.
- Derived from this study: PubMed 26259632Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.
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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.
Anne Nilsson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing test meal and reference meal in people with Metabolic Syndrome, 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 4 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 8 May 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Area under the plasma concentration versus time curve (AUC) of the test meal (time frame: Post-prandially after breakfast, 0-150 min). 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 NCT01718431, 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 8 May 2013.