NCT02379312

Brief Summary

To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

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

October 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
Last Updated

March 4, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

February 17, 2015

Last Update Submit

February 26, 2015

Conditions

SatietyAppetite

Keywords

FoamsSatietyAppetite

Outcome Measures

Primary Outcomes (1)

  • Hunger and satiety questions

    Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)

    Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min

Secondary Outcomes (1)

  • Electronic Visual Analogue Scale (EVAS) for liking questions

    Time point 15 min

Study Arms (4)

Very low energy aerated beverage

ACTIVE COMPARATOR

Very low energy aerated beverage

Dietary Supplement: Very low energy aerated beverage

Normal energy aerated beverage 1

ACTIVE COMPARATOR

Normal energy aerated beverage 1

Dietary Supplement: Normal energy aerated beverage 1

Normal energy aerated beverage 2

ACTIVE COMPARATOR

Normal energy aerated beverage 2

Dietary Supplement: Normal energy aerated beverage 2

Normal energy aerated beverage 3

ACTIVE COMPARATOR

Normal energy aerated beverage 3

Dietary Supplement: Normal energy aerated beverage 3

Interventions

Very low energy aerated beverageDIETARY_SUPPLEMENT
Very low energy aerated beverage
Normal energy aerated beverage 1DIETARY_SUPPLEMENT
Normal energy aerated beverage 1
Normal energy aerated beverage 2DIETARY_SUPPLEMENT
Normal energy aerated beverage 2
Normal energy aerated beverage 3DIETARY_SUPPLEMENT
Normal energy aerated beverage 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 20 and 30 kg/m² (inclusive)
  • Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).

You may not qualify if:

  • Dislike, allergy or intolerance to test products
  • Eating disorder (measured by SCOFF questionnaire, \> 2 "yes" responses)
  • High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score \> 14
  • Reported medical treatment that may affect eating habits/satiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Isabelle Blanc, PhD

    Eurofins Optimed

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 4, 2015

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 4, 2015

Record last verified: 2015-01