- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034605
The Effect of PinnoThin on Satiety and Food Intake (PinnoThin)
August 29, 2012 updated by: Maastricht University Medical Center
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 Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- age over 18 and under 45
- women
- BMI over 23 and under 30
- breakfast eaters
Exclusion Criteria:
- men
- age under 18 and over 45
- BMI under 23 and over 30
- use of medication
- pregnant and breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: inulin
oligofructose
|
6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
appetite profile ratings
Time Frame: 10 timepoints
|
10 timepoints
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
energy intake
Time Frame: 3.5 hours after PinnoThin
|
3.5 hours after PinnoThin
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Klaas R Westerterp, Prof, NUTRIM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (Estimate)
December 17, 2009
Study Record Updates
Last Update Posted (Estimate)
August 30, 2012
Last Update Submitted That Met QC Criteria
August 29, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- HumBio_Westerterp08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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