ThirstNCT01502722
Effect of Ingestion of Sugary Drinks on Thirst Sensation
A study testing Effect of ingestion sugary and sweetened drinks on thirst in people with Thirst, run by Universidade do Porto at 1 site in Portugal.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thirst
- What is being tested?
- Effect of ingestion sugary and sweetened drinks on thirst
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant and nursing women
- smokers
- athletes
- subjects under medication(except oral contraceptives in women)
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto
Porto, Porto District, 4200-465
About this study
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).
Read the 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.
- Conditions
- Thirst
- Being tested
- Effect of ingestion sugary and sweetened drinks on thirst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of ingestion sugary and sweetened drinks on thirstBehavioural
Also called Effect of ingestion of water, soda and diet soda on thirst, Diferences between sweeteners and sugar on thirst
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Crossover | Experimental | This group will drink water in the 1st study. Receives: Behavioral: Effect of ingestion sugary and sweetened drinks on thirst |
| Group 2 - Crossover | Experimental | This group will drink Pineapple Soda in the 1st study Receives: Behavioral: Effect of ingestion sugary and sweetened drinks on thirst |
| Group 3 - Crossover | Experimental | This group will drink Pineapple Diet Soda in the 3rd study Receives: Behavioral: Effect of ingestion sugary and sweetened drinks on thirst |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
Food Behavior After Intervention
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.
Measured: 1 day
Amount of water ingested
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThirstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Miguel Fernandes Ramos de Carvalho, Universidade do Porto
- Investigators
- Pedro R Carvalho, PhD Student, Principal investigator, Faculdade de Ciências da Nutrição e Alimentação - Universidade do PortoVitor H Teixeira, PhD, Study director, Faculdade de Ciências da Nutrição e Alimentação - Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502722
- Sponsor's protocol ID
- IHS/FCNAUP-001
- Status last verified
- Jan 2013
- First submitted
- 22 Nov 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17616770Almiron-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.
PubMed 12954421
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ingestion of Sugary Drinks on Thirst Sensation
- ClinicalTrials.gov ID
- NCT01502722
- Acronym / sponsor ID
- IHS/FCNAUP-001
- Conditions
- Thirst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Crossover | Experimental | Behavioral: Effect of ingestion sugary and sweetened drinks on thirstThis group will drink water in the 1st study. |
| Group 2 - Crossover | Experimental | Behavioral: Effect of ingestion sugary and sweetened drinks on thirstThis group will drink Pineapple Soda in the 1st study |
| Group 3 - Crossover | Experimental | Behavioral: Effect of ingestion sugary and sweetened drinks on thirstThis group will drink Pineapple Diet Soda in the 3rd study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- pregnant and nursing women
- smokers
- athletes
- subjects under medication(except oral contraceptives in women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effect of ingestion sugary and sweetened drinks on thirstAlso: Effect of ingestion of water, soda and diet soda on thirst, Diferences between sweeteners and sugar on thirstThe 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. | Behavioural | Group 1 - Crossover, Group 2 - Crossover, Group 3 - Crossover |
Primary outcome
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
2 secondary outcomes
Food Behavior After Intervention
Time frame: 1 day
Amount of water ingested
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Background: PubMed 17616770Monsivais 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.
- Background: PubMed 12954421Almiron-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro R Carvalho, PhD Student principal investigator
Faculdade de Ciências da Nutrição e Alimentação - Universidade do Porto
Vitor H Teixeira, PhD study director
Faculdade de Ciências da Nutrição e Alimentação - Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of ingestion sugary and sweetened drinks on thirst in people with Thirst, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivational Ratings (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502722, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.