ThirstNCT01770327
Influence of Different Sugary Beverages on Thirst Sensation
A study testing Effect of ingestion of different Sugary Beverages on Thirst Sensation 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 water and three different sugary beverages (milk, Orange juice and iced tea) have the same effect on thirst. 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 of different Sugary Beverages on Thirst Sensation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- Jun 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 - 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
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
Faculty of Nutrition and Food Sciences - University of Porto
Porto, Porto District, 4200-465
About this study
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.
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, osmolality and plasmatic sodium. 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 of different Sugary Beverages on Thirst Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of ingestion of different Sugary Beverages on Thirst SensationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (placebo) - Water | Placebo comparator | This group will drink water in 1st trial Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Effect of ingestion of different Sugary Beverages on Thirst Sensation |
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 (6)
Glycaemia
Glycaemia will be assessed before and after the ingestion of beverages
Measured: 1 day
Amount of water ingested
After the ingestion of 3 preloads with the beverages in study, the participants will lunch the same meal with free water ingestion.
Measured: 1 day
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
Blood osmolality
Blood osmolality will be assessed before and after the ingestion of beverages
Measured: 1 day
Plasmatic Sodium
Plasmatic sodium will be measured before and after the ingestion of the beverages.
Measured: 1 day
Hydration parameters
Total body water, intra and extracellular body water will me measured before and after the ingestion of the beverages
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 posted17 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 32 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, FCNAUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770327
- Sponsor's protocol ID
- EHI-FCNAUP
- Other IDs
- Nº30/CEUP/2011_2
- Status last verified
- Jan 2013
- First submitted
- 15 Jan 2013
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Sugary Beverages on Thirst Sensation
- ClinicalTrials.gov ID
- NCT01770327
- Acronym / sponsor ID
- EHI-FCNAUP
- Conditions
- Thirst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Jan 2013 (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 water and three different sugary beverages (milk, Orange juice and iced tea) have the same effect on thirst.
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, osmolality and plasmatic sodium. 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (placebo) - Water | Placebo comparator | Behavioral: Effect of ingestion of different Sugary Beverages on Thirst SensationThis group will drink water in 1st trial |
| Group 2 (Intervention) - Milk | Experimental | Behavioral: Effect of ingestion of different Sugary Beverages on Thirst SensationThis group will drink Non-Fat Milk in 1st trial |
| Group 3 (Intervention) - Orange Juice | Experimental | Behavioral: Effect of ingestion of different Sugary Beverages on Thirst SensationThis group will drink Orange Juice in 1st trial |
| Group 4 (Intervention) - Iced Tea | Experimental | Behavioral: Effect of ingestion of different Sugary Beverages on Thirst SensationThis group will drink Iced Tea in 1st 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 - 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
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 of different Sugary Beverages on Thirst SensationThe 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. | Behavioural | Group 1 (placebo) - Water, Group 2 (Intervention) - Milk, Group 3 (Intervention) - Orange Juice, Group 4 (Intervention) - Iced Tea |
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.
6 secondary outcomes
Glycaemia
Time frame: 1 day
Amount of water ingested
Time frame: 1 day
Food Behavior After Intervention
Time frame: 1 day
Blood osmolality
Time frame: 1 day
Plasmatic Sodium
Time frame: 1 day
Hydration parameters
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 21 Jan 2013.
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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
FCNAUP
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 of different Sugary Beverages on Thirst Sensation 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 21 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. Some participants in this study may receive a placebo. 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?
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 21 Jan 2013.