ObesityPinnoThinNCT01034605
The Effect of PinnoThin on Satiety and Food Intake
A study testing PinnoThin in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1), PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans. Therefore, the objective of this study is to investigate whether PinnoThin leads to an increase in satiety as determined by VAS ratings?… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- PinnoThin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Jan 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age over 18 and under 45
- women
- BMI over 23 and under 30
- breakfast eaters
Who cannot join
- men
- age under 18 and over 45
- BMI under 23 and over 30
- use of medication
- pregnant and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1), PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans. Therefore, the objective of this study is to investigate whether PinnoThin leads to an increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy intake during an ad libitum lunch?
- Conditions
- Obesity
- Being tested
- PinnoThin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PinnoThinDietary supplement
6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose
| Study group | Role | What they receive |
|---|---|---|
| inulin | Experimental | oligofructose Receives: Dietary Supplement: PinnoThin |
What is being measured
The primary outcome is the main question the study is designed to answer.
appetite profile ratings
Measured: 10 timepoints
Secondary outcomes (1)
energy intake
Measured: 3.5 hours after PinnoThin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
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 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
- 40 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
- NCT01034605
- Sponsor's protocol ID
- HumBio_Westerterp08
- Acronym
- PinnoThin
- Status last verified
- Aug 2012
- First submitted
- 2 Dec 2009
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verhoef SP, Westerterp KR. No effects of Korean pine nut triacylglycerol on satiety and energy intake. Nutr Metab (Lond). 2011 Nov 10;8(1):79. doi: 10.1186/1743-7075-8-79.
PubMed 22074178
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
- The Effect of PinnoThin on Satiety and Food Intake
- ClinicalTrials.gov ID
- NCT01034605
- Acronym / sponsor ID
- PinnoThin / HumBio_Westerterp08
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 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.
Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1), PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans. Therefore, the objective of this study is to investigate whether PinnoThin leads to an increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy intake during an ad libitum lunch?
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inulin | Experimental | Dietary Supplement: PinnoThinoligofructose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age over 18 and under 45
- women
- BMI over 23 and under 30
- breakfast eaters
Key exclusion criteria (5 listed)
- men
- age under 18 and over 45
- BMI under 23 and over 30
- use of medication
- pregnant and 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 |
|---|---|---|
| PinnoThin6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose | Dietary supplement | inulin |
Primary outcome
appetite profile ratings
Time frame: 10 timepoints
1 secondary outcome
energy intake
Time frame: 3.5 hours after PinnoThin
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.
- Derived from this study: PubMed 22074178Verhoef SP, Westerterp KR. No effects of Korean pine nut triacylglycerol on satiety and energy intake. Nutr Metab (Lond). 2011 Nov 10;8(1):79. doi: 10.1186/1743-7075-8-79.
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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 PinnoThin 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 4 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?
appetite profile ratings (time frame: 10 timepoints). 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 NCT01034605, 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 30 Aug 2012.