NCT01034605

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

December 2, 2009

Last Update Submit

August 29, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • appetite profile ratings

    10 timepoints

Secondary Outcomes (1)

  • energy intake

    3.5 hours after PinnoThin

Study Arms (1)

inulin

EXPERIMENTAL

oligofructose

Dietary Supplement: PinnoThin

Interventions

PinnoThinDIETARY_SUPPLEMENT

6.0 gram of the oil extract from the korean pine nut (PinnoThin) as a single dose

inulin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age over 18 and under 45
  • women
  • BMI over 23 and under 30
  • breakfast eaters

You may not qualify if:

  • men
  • age under 18 and over 45
  • BMI under 23 and over 30
  • use of medication
  • pregnant and breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22074178DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Klaas R Westerterp, Prof

    NUTRIM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 17, 2009

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

NL(1)