NCT02615613

Brief Summary

30-40 healthy male subjects with a BMI between 18.5 and 24.9 kg/m2 will be tested for food preferences using a questionnaire with 141 different foods. Accordingly, a high acceptability/palatability food will be selected (average score of ≥ 7 on the 9-point hedonic scale). Two versions of the selected high palatability food will be devised by modifying it to yield the original high and the modified low acceptability versions. The two versions will differ only in palatability and will be equicaloric. Subjects who agree on the acceptability of the two versions of the food (11 subjects) will consume, at fasting, the two versions of the food in a cross over design over two sessions. Each session will include an acceptability test, using the 9-point hedonic scale, on three instances: after sampling a spoonful, eating the whole portion and after 240 min. The quantity consumed on each session will constitute 30% of the subject's resting energy expenditure. Moreover, fasting and postprandial hunger ratings and blood samples will be collected at time 0 and after 15, 30, 60, 120, 180 and 240 min of the food/meal's ingestion. The visual analogue scale will be used for huger ratings.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

November 25, 2015

Last Update Submit

November 26, 2015

Conditions

Keywords

Hedonics, Ghrelin, Hunger

Outcome Measures

Primary Outcomes (2)

  • Food acceptability score

    Two weeks

  • Ghrelin level

    Two weeks

Secondary Outcomes (3)

  • Glucose level

    Two weeks

  • Appetite score on the visual analogue scale

    Two weeks

  • Insulin level

    2 weeks

Study Arms (2)

High acceptability meal

EXPERIMENTAL

A custard recipe was used as the high acceptability meal

Other: High acceptability meal

Low acceptability meal

EXPERIMENTAL

The regular custard recipe was reformulated to yield a low acceptability version

Other: Low Acceptability Meal

Interventions

Low acceptability meal
High acceptability meal

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gender: Male
  • Age: 18-50 years
  • Body Mass Index (BMI): 18.5-24.9 kg/m2
  • Stable body weight for at least three months before the study with absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize effect of weight change on ghrelin status)

You may not qualify if:

  • Smoking
  • Substance abuse such as alcohol or drugs
  • Medical or psychological illness
  • Use of medications
  • Previous gastrointestinal surgery
  • History of weight fluctuation (weight loss of greater than 5% within the past 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2015

First Posted

November 26, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11