Profiling the Endocannabinoid Response to Hedonic Eating (Lekkere trek)

Study into the endocannabinoid response to consuming a palatable versus a neutral food.

Study Overview

• Status: Completed
• Conditions: Obesity; Food Preferences
• Intervention / Treatment: Other: Food palatability

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy (self-report)
• Dutch
• Evaluating one of the used foods as palatable
• Evaluating one of the used foods as neutral
• Hb value between 8.1 and 11.0 mmol/L at screening

Exclusion Criteria:

• restraint eating
• lack of appetite
• difficulties eating/swallowing
• endocrine disorders
• energy restricted diet two months prior to study
• weight change > 5 kg in two months prior to study
• stomach or bowel disease
• taste or smell disorders (self-report)
• not consuming foods used in the study
• smoking > 1 cigarette per day
• drinking > 21 units alcohol per week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palatable-neutral; Participants are exposed to palatable food in the first test session, and to the neutral food in the second test session.	Other: Food palatability; Food palatability is modulated
Experimental: Neutral-palatable; Participants are exposed to neutral food in the first test session, and to the palatable food in the second test session.	Other: Food palatability; Food palatability is modulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocannainoid levels	To assess changes in endocannabinoid plasma levels prior to, during and after eating a palatable versus a neutral food	prior to, during and two hours after eating

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatic polypeptide (pg/ml)	To assess changes in pancreatic polypeptide plasma levels prior to, during and after eating a palatable versus a neutral food	prior to, during and two hours after eating
Ghrelin (pg/ml)	To assess changes in ghrelin plasma levels prior to, during and after eating a palatable versus a neutral food	prior to, during and two hours after eating

Collaborators and Investigators

• Sponsor: Wageningen University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Actual): October 8, 2015
• Study Completion (Actual): October 8, 2015

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 9, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NL51830.081.14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No