ObesityEarly Phase 1NCT02093481
Effects of Dietary Fibre on Glucose Metabolism and Satiety
A Early Phase 1 study testing Test meal, Reference and Priming in people with Obesity and Metabolic Syndrome, run by Lund University at 1 site in Sweden.
Trial summary
The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects. 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, Reference and Priming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Jun 2014
- 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
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 study. Vegetarians.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Applied Nutrition and Food Chemistry, Lund Univeristy
Lund, SE, 221 00
About this study
Official title: Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Test meal, Reference, Priming, No priming
- 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
PrimingOther
The reference or test meal was eaten 3 days prior to measurements of variables.
No primingOther
The reference or test meal was eaten 1 days prior to measurements of variables.
| Study group | Role | What they receive |
|---|---|---|
| + ind. CHO + prim | Experimental | Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming) Receives: Other: Test meal; Other: Priming |
| - ind. CHO + prim | Experimental | Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming) Receives: Other: Reference; Other: Priming |
| + ind. CHO - prim | Experimental | Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming) Receives: Other: Test meal; Other: No priming |
| - ind. CHO - prim | Experimental | Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming). Receives: Other: Reference; Other: No priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
The test products are both ingested one day and three days prior to measurements of variables.
Measured: Postprandial 0-180 min after breakfast
Insulin
The test products are both ingested one day and three days prior to measurements of variables.
Measured: Postprandial 0-180 min after breakfast
Appetite hormones
The test products are both ingested one day and three days prior to measurements of variables.
Measured: Postprandial 0-180 min after breakfast
Markers of colonic fermentation and inflammation
The test products are both ingested one day and three days prior to measurements of variables.
Measured: Postprandial 0-180 min after breakfast
Secondary outcomes (1)
Subjective satiety
The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.
Measured: Postprandial 0-180 min after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonna Sandberg, Lund University
- Investigators
- Anne Nilsson, PhD, Principal investigator, Lund Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093481
- Sponsor's protocol ID
- Dnr2013/241
- Status last verified
- Jun 2014
- First submitted
- 10 Mar 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
PubMed 26990559
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
- ClinicalTrials.gov ID
- NCT02093481
- Acronym / sponsor ID
- Dnr2013/241
- Conditions
- Obesity, Metabolic Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Mar 2014 (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 experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| + ind. CHO + prim | Experimental | Other: Test meal, Other: PrimingTest meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming) |
| - ind. CHO + prim | Experimental | Other: Reference, Other: PrimingReference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming) |
| + ind. CHO - prim | Experimental | Other: Test meal, Other: No primingTest meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming) |
| - ind. CHO - prim | Experimental | Other: Reference, Other: No primingReference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming). |
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
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 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 + prim, + ind. CHO - prim |
| Reference | Other | - ind. CHO + prim, - ind. CHO - prim |
| PrimingThe reference or test meal was eaten 3 days prior to measurements of variables. | Other | + ind. CHO + prim, - ind. CHO + prim |
| No primingThe reference or test meal was eaten 1 days prior to measurements of variables. | Other | + ind. CHO - prim, - ind. CHO - prim |
Primary outcome
Blood glucose
Time frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Insulin
Time frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Appetite hormones
Time frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Markers of colonic fermentation and inflammation
Time frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
1 secondary outcome
Subjective satiety
Time frame: Postprandial 0-180 min after breakfast
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 26 Jun 2014.
- Derived from this study: PubMed 26990559Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
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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 Univeristy
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, Reference and Priming 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 26 Jun 2014. 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?
Blood glucose (time frame: Postprandial 0-180 min after breakfast). The study lists 4 primary outcomes in all. 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 NCT02093481, 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 26 Jun 2014.