- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770327
Influence of Different Sugary Beverages on 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
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
Exclusion Criteria:
- pregnant and nursing women
- smokers
- athletes
- subjects under medication(except oral contraceptives in women)
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
|
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.
|
|
Experimental: Group 2 (Intervention) - Milk
This group will drink Non-Fat Milk in 1st trial
|
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.
|
|
Experimental: Group 3 (Intervention) - Orange Juice
This group will drink Orange Juice in 1st trial
|
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.
|
|
Experimental: Group 4 (Intervention) - Iced Tea
This group will drink Iced Tea in 1st study
|
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.
|
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 |
|---|---|---|
|
Glycaemia
Time Frame: 1 day
|
Glycaemia 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
|
|
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
|
|
Blood osmolality
Time Frame: 1 day
|
Blood osmolality will be assessed before and after the ingestion of beverages
|
1 day
|
|
Plasmatic Sodium
Time Frame: 1 day
|
Plasmatic sodium will be measured before and after the ingestion of the beverages.
|
1 day
|
|
Hydration parameters
Time Frame: 1 day
|
Total body water, intra and extracellular body water will me measured before and after the ingestion of the beverages
|
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
- EHI-FCNAUP
- Nº30/CEUP/2011_2
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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