The Effect of PinnoThin on Satiety and Food Intake | NCT01034605

Studies
The Effect of PinnoThin on Satiety and Food Intake

NCT01034605

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Aug 30, 2012Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

PinnoThin

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 16, 2009

First Posted Date

Dec 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2012

Last Update Posted Date

Aug 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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? 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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inulin	Experimental	oligofructose	Dietary Supplement: PinnoThin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PinnoThin	Dietary Supplement	6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose	inulin

Measure	Description	Time Frame
appetite profile ratings		10 timepoints

Measure	Description	Time Frame
energy intake		3.5 hours after PinnoThin

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaas R Westerterp, Prof	NUTRIM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht	Limburg	6229ER	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22074178	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases