NCT01771094

Brief Summary

The purpose of this study is to determine if water and diet soft drinks with different levels of sweeteners have the same effect on thirst.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

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

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

January 15, 2013

Last Update Submit

January 15, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motivational Ratings

    Participants will rate their hunger, thirst, nausea, mouth dryness, desire to eat, desire to drink using nine point category scales. The unipolar adjective scales were anchored at each end with labels: 1 = not at all and 9 = extremely. Participants also rated their perception about beverage sweetness along nine point hedonic preference scales where 1 = no sweet at all and 9 = extremely sweet

    1 day

Secondary Outcomes (3)

  • Food Behavior After Intervention

    1 day

  • Physiological Parameters

    1 day

  • Amount of water ingested

    1 day

Study Arms (3)

Group 1 (placebo) - Water

PLACEBO COMPARATOR

This group will drink water in 1st trial

Behavioral: Effect of sweetness of the beverage in thirst sensation

Group 3 (Intervention) - "Low" Sucralose

EXPERIMENTAL

This group will drink Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage in 1st trial

Behavioral: Effect of sweetness of the beverage in thirst sensation

Group 2(Intervention)-"High" Sucralose

EXPERIMENTAL

This group will drink Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage in 1st trial

Behavioral: Effect of sweetness of the beverage in thirst sensation

Interventions

Effect of sweetness of the beverage in thirst sensation: The participants will drink Water (control group),"High Sucralose" - Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage, and "Low Sucralose" - Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage. The beverages will be presented chilled but without ice in 500 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min.

Group 1 (placebo) - WaterGroup 2(Intervention)-"High" SucraloseGroup 3 (Intervention) - "Low" Sucralose

Eligibility Criteria

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

You may not qualify if:

  • pregnant and nursing women
  • smokers
  • athletes
  • subjects under medication(except oral contraceptives in women)
  • body mass index(BMI) between (18,5 - 27,5 kg/m2)
  • regular consumers of breakfast
  • stable in weight for the past 6 months
  • not dieting to gain or lose weight
  • like all drinks and food available in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nutrition and Food Sciences - University of Porto

Porto, Porto District, 4200-465, Portugal

Location

Study Officials

  • Pedro R Carvalho, PhD Student

    FCNAUP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Invited Assistant

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 18, 2013

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations