ObesityEarly Phase 1NCT01718418
Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach
A Early Phase 1 study testing test meal and reference in people with Obesity and Metabolic Syndrome, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- test meal and reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Dec 2012
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives
Who cannot join
- gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians
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 and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- test meal, reference
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test mealOther
referenceOther
| Study group | Role | What they receive |
|---|---|---|
| + ind.CHO + prebiotics | Experimental | test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement. Receives: Other: test meal |
| + ind.CHO - prebiotics | Experimental | test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement. Receives: Other: test meal |
| - ind.CHO - prebiotics | Experimental | reference: no ind. carbohydrates and no probiotic supplement Receives: Other: reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.
Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.
Measured: Post-prandially after breakfast, 0-210 min
Secondary outcomes (3)
voluntary energy intake
Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.
Measured: Post-prandially after breakfast, 0-210 min
Subjective satiety
The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.
Measured: post-prandially after breakfast, 0-210 min
Differences in gut microbiota
The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.
Measured: Faecal samples are collected after 14 days intake of test- and reference product
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 startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
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 ObesityStudies 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
- 21 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
- NCT01718418
- Sponsor's protocol ID
- Dnr2010/457
- Status last verified
- May 2013
- First submitted
- 9 Oct 2012
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.
PubMed 28531784
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 and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
- ClinicalTrials.gov ID
- NCT01718418
- Acronym / sponsor ID
- Dnr2010/457
- Conditions
- Obesity, Metabolic Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (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.
The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| + ind.CHO + prebiotics | Experimental | Other: test mealtest meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement. |
| + ind.CHO - prebiotics | Experimental | Other: test mealtest meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement. |
| - ind.CHO - prebiotics | Experimental | Other: referencereference: no ind. carbohydrates and no probiotic supplement |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives
Key exclusion criteria (1 listed)
- gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians
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 | + ind.CHO + prebiotics, + ind.CHO - prebiotics |
| reference | Other | - ind.CHO - prebiotics |
Primary outcome
Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.
Time frame: Post-prandially after breakfast, 0-210 min
Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.
3 secondary outcomes
voluntary energy intake
Time frame: Post-prandially after breakfast, 0-210 min
Subjective satiety
Time frame: post-prandially after breakfast, 0-210 min
Differences in gut microbiota
Time frame: Faecal samples are collected after 14 days intake of test- and reference product
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 28531784Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.
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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 in people with Obesity and 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 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 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?
Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal. (time frame: Post-prandially after breakfast, 0-210 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 NCT01718418, 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.