- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771094
Effect of Sweetness of the Beverage in Thirst Sensation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Porto, Portugal, 4200-465
- Faculty of Nutrition and Food Sciences - University of Porto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion Criteria:
- pregnant and nursing women
- smokers
- athletes
- subjects under medication(except oral contraceptives in women)
Inclusion Criteria:
- 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
Study Plan
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 |
|---|---|
|
Placebo Comparator: Group 1 (placebo) - Water
This group will drink water in 1st trial
|
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. |
|
Experimental: Group 3 (Intervention) - "Low" Sucralose
This group will drink Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage in 1st trial
|
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. |
|
Experimental: Group 2(Intervention)-"High" Sucralose
This group will drink Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage in 1st trial
|
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. |
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 perception about beverage sweetness along nine point hedonic preference scales where 1 = no sweet at all and 9 = extremely sweet
|
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
|
|
Physiological Parameters
Time Frame: 1 day
|
Glycaemia, blood osmolality and hydration parameters (total body water, intra and extracellular body water) will be assessed before and after the ingestion of beverages
|
1 day
|
|
Amount of water ingested
Time Frame: 1 day
|
After the ingestion of 3 preloads with the beverages in study, the participants will lunch the same meal with free water ingestion
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pedro R Carvalho, PhD Student, FCNAUP
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IHS/FCNAUP-002
- Nº30/CEUP/2011
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.