NCT01770327

Brief Summary

The purpose of this study is to determine if water and three different sugary beverages (milk, Orange juice and iced tea) 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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

January 15, 2013

Last Update Submit

January 18, 2013

Conditions

Thirst

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 liking for the beverage along nine point hedonic preference scales where 1 = dislike extremely and 9 = like extremely.

    1 day

Secondary Outcomes (6)

  • Glycaemia

    1 day

  • Amount of water ingested

    1 day

  • Food Behavior After Intervention

    1 day

  • Blood osmolality

    1 day

  • Plasmatic Sodium

    1 day

  • +1 more secondary outcomes

Study Arms (4)

Group 1 (placebo) - Water

PLACEBO COMPARATOR

This group will drink water in 1st trial

Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation

Group 2 (Intervention) - Milk

EXPERIMENTAL

This group will drink Non-Fat Milk in 1st trial

Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation

Group 3 (Intervention) - Orange Juice

EXPERIMENTAL

This group will drink Orange Juice in 1st trial

Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation

Group 4 (Intervention) - Iced Tea

EXPERIMENTAL

This group will drink Iced Tea in 1st study

Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation

Interventions

Effect of ingestion of different Sugary Beverages on Thirst SensationBEHAVIORAL

The participants will drink Water (control group),Non-fat Milk, Orange Juice and Iced Tea. The beverages will be presented chilled but without ice in 330 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) - MilkGroup 3 (Intervention) - Orange JuiceGroup 4 (Intervention) - Iced Tea

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • pregnant and nursing women
  • smokers
  • athletes
  • subjects under medication(except oral contraceptives in women)

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 17, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

PT(1)