ObesityEarly Phase 1NCT02347293
Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
A Early Phase 1 study testing High levels of indigestible carbohydrates and Low levels of indigestible carbohydrates 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, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation 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?
- High levels of indigestible carbohydrates and Low levels of indigestible carbohydrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to May 2015
- 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
- Food allergies e.g. lactose-, gluten intolerance
- Metabolic disorder e.g. diabetes
- Tobacco/snuff users
- No antibiotic or probiotic intake 2 weeks prior and during study.
- Vegetarians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- High levels of indigestible carbohydrates, Low levels of indigestible carbohydrates
- 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.
High levels of indigestible carbohydratesOther
Low levels of indigestible carbohydratesOther
| Study group | Role | What they receive |
|---|---|---|
| + ind. CHO | Experimental | Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables Receives: Other: High levels of indigestible carbohydrates |
| - ind. CHO | Experimental | Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables Receives: Other: Low levels of indigestible carbohydrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose, levels of glucose in blood
Measured: Postprandial 0-180 min after breakfast
Insulin, levels of insulin in blood
Measured: Postprandial 0-180 min after breakfast
Appetite hormones, levels of Peptide YY (PYY) in blood
Measured: Postprandial 0-180 min after breakfast
Markers of colonic fermentation, levels of hydrogen in breath
Measured: Postprandial 0-180 min after breakfast
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
Measured: Postprandial 0-180 min after breakfast
Secondary outcomes (1)
Subjective satiety, as measured by VAS
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 posted27 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 21 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347293
- Sponsor's protocol ID
- Dnr2013/241b
- Status last verified
- May 2015
- First submitted
- 15 Jan 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1.
PubMed 29338758Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
PubMed 28431559
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
- ClinicalTrials.gov ID
- NCT02347293
- Acronym / sponsor ID
- Dnr2013/241b
- 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
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Jan 2015 (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, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| + ind. CHO | Experimental | Other: High levels of indigestible carbohydratesTest meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables |
| - ind. CHO | Experimental | Other: Low levels of indigestible carbohydratesReference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal fasting blood glucose
- BMI 19-25 kg/m2
Key exclusion criteria (6 listed)
- Gastrointestinal diseases
- Food allergies e.g. lactose-, gluten intolerance
- Metabolic disorder e.g. diabetes
- Tobacco/snuff users
- No antibiotic or probiotic intake 2 weeks prior and during study.
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 |
|---|---|---|
| High levels of indigestible carbohydrates | Other | + ind. CHO |
| Low levels of indigestible carbohydrates | Other | - ind. CHO |
Primary outcome
Blood Glucose, levels of glucose in blood
Time frame: Postprandial 0-180 min after breakfast
Insulin, levels of insulin in blood
Time frame: Postprandial 0-180 min after breakfast
Appetite hormones, levels of Peptide YY (PYY) in blood
Time frame: Postprandial 0-180 min after breakfast
Markers of colonic fermentation, levels of hydrogen in breath
Time frame: Postprandial 0-180 min after breakfast
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
Time frame: Postprandial 0-180 min after breakfast
1 secondary outcome
Subjective satiety, as measured by VAS
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 27 May 2015.
- Derived from this study: PubMed 29338758Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1.
- Derived from this study: PubMed 28431559Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
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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.
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 High levels of indigestible carbohydrates and Low levels of indigestible carbohydrates 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 2 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 27 May 2015. 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, levels of glucose in blood (time frame: Postprandial 0-180 min after breakfast). The study lists 5 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 NCT02347293, which also lists 2 linked publications.
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 27 May 2015.