NCT03134365

Brief Summary

Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days. Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2016

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

April 25, 2017

Last Update Submit

April 25, 2017

Conditions

Keywords

meal ingestionpalatabilitypostprandial responseshedonic response

Outcome Measures

Primary Outcomes (2)

  • Meal palatability

    Meal palatability measured by 10 score scales at the end of the test meal

    1 day

  • Change in digestive well-being measured after the test meal

    Change in average well-being measured by 10 score scales at the end of the test meal.

    1 day

Secondary Outcomes (4)

  • Change in satiety measured after the test meal

    1 day

  • Change in fullness sensation measured after the test meal

    1 day

  • Change in abdominal discomfort/pain sensation measured after the test meal

    1 day

  • Change in mood measured after the test meal

    1 day

Study Arms (2)

Mixed meal

EXPERIMENTAL
Other: Mixed meal

Combined meal

ACTIVE COMPARATOR
Other: Combined meal

Interventions

Mixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability.

Mixed meal

Combined meal.

Combined meal

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non obese

You may not qualify if:

  • history of gastrointestinal symptoms
  • prior obesity
  • use of medications
  • history of anosmia and ageusia
  • current dieting
  • alcohol abuse
  • psychological disorders
  • eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

August 4, 2016

Primary Completion

November 23, 2016

Study Completion

December 2, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations