ObesityInulinNCT01025375
Effects of Inulin on Satiety and Food Intake
A study testing inulin in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Feb 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 60 years
- BMI between 23 and 28 kg/m2
- dietary unrestraint (TFEQ: F1<9)
Who cannot join
- age under 18 and above 60 years
- BMI under 23 and above 28 kg/m2
- dietary restraint (TFEQ: F1>9)
- use of medication
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.
Read the detailed description
Based upon a slower digestion and the fermentation in the intestinal tract, food containing soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit energy intake, in humans. Does supplementation of inulin (at 2 dosages) versus placebo over 13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a reduction in food intake and stronger postprandial increases in GLP-1 and PYY?
- Conditions
- Obesity
- Being tested
- inulin, placebo
- Keywords
- overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinDietary supplement
Also called oligofructose
10gram/day inulin for 13-day treatment
inulinDietary supplement
Also called oligofructose
16gram/day inulin for 13-day treatment
placeboDietary supplement
Also called maltodextrin
16gram/day maltodextrin (placebo) for 13-day treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
food intake
Measured: on testday 0 and 13
Secondary outcomes (2)
appetite profile ratings
Measured: on test day 0, 8 and 13 (at 16 time points)
satiety hormones (GLP-1 and PYY)
Measured: on test day 0 and 13 (at 9 time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaas R Westerterp, Prof, Principal investigator, NUTRIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025375
- Sponsor's protocol ID
- HumBio_Westerterp08_2
- Acronym
- Inulin
- Status last verified
- Aug 2012
- First submitted
- 2 Dec 2009
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inulin on Satiety and Food Intake
- ClinicalTrials.gov ID
- NCT01025375
- Acronym / sponsor ID
- Inulin / HumBio_Westerterp08_2
- Conditions
- Obesity
- Keywords
- overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Dec 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.
To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.
Detailed description
Based upon a slower digestion and the fermentation in the intestinal tract, food containing soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit energy intake, in humans. Does supplementation of inulin (at 2 dosages) versus placebo over 13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a reduction in food intake and stronger postprandial increases in GLP-1 and PYY?
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 60 years
- BMI between 23 and 28 kg/m2
- dietary unrestraint (TFEQ: F1<9)
Key exclusion criteria (5 listed)
- age under 18 and above 60 years
- BMI under 23 and above 28 kg/m2
- dietary restraint (TFEQ: F1>9)
- use of medication
- pregnant or breastfeeding
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 |
|---|---|---|
| inulinAlso: oligofructose10gram/day inulin for 13-day treatment | Dietary supplement | – |
| inulinAlso: oligofructose16gram/day inulin for 13-day treatment | Dietary supplement | – |
| placeboAlso: maltodextrin16gram/day maltodextrin (placebo) for 13-day treatment | Dietary supplement | – |
Primary outcome
food intake
Time frame: on testday 0 and 13
2 secondary outcomes
appetite profile ratings
Time frame: on test day 0, 8 and 13 (at 16 time points)
satiety hormones (GLP-1 and PYY)
Time frame: on test day 0 and 13 (at 9 time points
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 Aug 2012.
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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.
Klaas R Westerterp, Prof principal investigator
NUTRIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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 Aug 2012. 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 Netherlands. 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.
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?
food intake (time frame: on testday 0 and 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2012.