NCT03113474

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable obesity

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

September 15, 2015

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

23 days

First QC Date

April 9, 2017

Last Update Submit

May 22, 2017

Conditions

ObesityFood Preferences

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pancreatic polypeptide (pg/ml)

    prior to, during and two hours after eating

  • Ghrelin (pg/ml)

    prior to, during and two hours after eating

Study Arms (2)

Palatable-neutral

EXPERIMENTAL

Participants are exposed to palatable food in the first test session, and to the neutral food in the second test session.

Other: Food palatability

Neutral-palatable

EXPERIMENTAL

Participants are exposed to neutral food in the first test session, and to the palatable food in the second test session.

Other: Food palatability

Interventions

Food palatabilityOTHER

Food palatability is modulated

Neutral-palatablePalatable-neutral

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityFood Preferences

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2017

First Posted

April 13, 2017

Study Start

September 15, 2015

Primary Completion

October 8, 2015

Study Completion

October 8, 2015

Last Updated

May 24, 2017

Record last verified: 2017-05