- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502722
Effect of Ingestion of Sugary Drinks on Thirst Sensation
January 15, 2013 updated by: Pedro Miguel Fernandes Ramos de Carvalho, Universidade do Porto
The purpose of this study is to determine if regular soft drinks (with sugar) have the same effect on thirst as diet soft drinks(with sweeteners).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants should be in the laboratory at 8.00 in order to collect the values of weight, height, total body water, intracellular water and extracellular water in a Segmental Multi Frequency Body Composition Monitor (TANITA MC 180 MA®).
Then, a blood sample will be collected for analysis of blood glucose and osmolality.
They will sit at individual tables for the duration of the session and were allowed to read, listen to music with earphones, or use their portable computers with the exception of internet access to minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and drinks), which may have effect on thirst.
Breakfast will be served at 9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30).
Lunch will be provided at 13.00.
Motivational ratings will be first obtained at the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times 1 through 7).
After lunch (time 8), participants will complete the last set of ratings and will bring a food diary to record all food and fluid intake until 00.00 that day.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Porto, Portugal, 4200-465
- Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- body mass index(BMI) between (18,5 - 25 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
Exclusion Criteria:
- pregnant and nursing women
- smokers
- athletes
- subjects under medication(except oral contraceptives in women)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 - Crossover
This group will drink water in the 1st study.
|
The participants will drink Water (control group), Decarbonized Pineapple Soda (11% sugar)and Decarbonized Pineapple Diet Soda (1% Sugar and Sucralose).
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.
The beverages will be tested previously in laboratory in order to obtain their pH and osmolality.
Other Names:
|
|
Experimental: Group 2 - Crossover
This group will drink Pineapple Soda in the 1st study
|
The participants will drink Water (control group), Decarbonized Pineapple Soda (11% sugar)and Decarbonized Pineapple Diet Soda (1% Sugar and Sucralose).
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.
The beverages will be tested previously in laboratory in order to obtain their pH and osmolality.
Other Names:
|
|
Experimental: Group 3 - Crossover
This group will drink Pineapple Diet Soda in the 3rd study
|
The participants will drink Water (control group), Decarbonized Pineapple Soda (11% sugar)and Decarbonized Pineapple Diet Soda (1% Sugar and Sucralose).
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.
The beverages will be tested previously in laboratory in order to obtain their pH and osmolality.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivational Ratings
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Behavior After Intervention
Time Frame: 1 day
|
After lunch, participants will bring a food diary to record all food and fluid intake until 00.00 that day.
Then, we will analyse total calories ingested, total fluid ingested and the volume of sugar and sugary beverages ingested.
|
1 day
|
|
Amount of water ingested
Time Frame: 1 day
|
After the ingestion of 3 preloads with the beverages in study (water, pineapple soda and pineapple diet soda), the participants will lunch the same meal bu the water ingestion will be ad libitum.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pedro R Carvalho, PhD Student, Faculdade de Ciências da Nutrição e Alimentação - Universidade do Porto
- Study Director: Vitor H Teixeira, PhD, Faculdade de Ciências da Nutrição e Alimentação - Universidade do Porto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Monsivais P, Perrigue MM, Drewnowski A. Sugars and satiety: does the type of sweetener make a difference? Am J Clin Nutr. 2007 Jul;86(1):116-23. doi: 10.1093/ajcn/86.1.116.
- Almiron-Roig E, Drewnowski A. Hunger, thirst, and energy intakes following consumption of caloric beverages. Physiol Behav. 2003 Sep;79(4-5):767-73. doi: 10.1016/s0031-9384(03)00212-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
November 22, 2011
First Submitted That Met QC Criteria
December 29, 2011
First Posted (Estimate)
January 2, 2012
Study Record Updates
Last Update Posted (Estimate)
January 16, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- IHS/FCNAUP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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