- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02735889
Fizzy Drinks Study
The Effect of Different Levels of Carbonation in Drinks on Glycemic Response, Gastric Emptying, Satiety and Energy Intake
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
15-20 healthy subjects will be recruited for the study by means of advertisements, flyers and personal communications.
A randomized, cross-over design experiment with three treatments will be carried out. Three different beverages will be prepared:- No carbonation (NC): Potable water + sugar- Low carbonation (LC): Potable water + sugar + little CO2- High carbonation (HC): Potable water + sugar+ high CO2.
The outcome measures assessed will be glycemic response, gastric emptying and satiety. Glycemic response will be measured by taking capillary blood samples (<5ul) by fingerpricking with one-time use sterilized lancets. Gastric emptying will be assessed by ultrasonography methodology developed by Okabe et al, 2015. Satiety will be measured using electronic visual analogue scales assessing hunger, fullness, desire to eat, prospective consumption and thirst. In addition, participants will be asked to rate the level of effervescence of beverage, sweetness of beverage, amount of beverage consumed, as well as how pleasant the beverage was immediately after drinking of test beverage. Feelings of bloatedness will be assessed using electronic visual analogue scales administered at 0, 15, 30, 45, 60, 90,120 min from drinking of test beverage. At the end of the test session, ad libitum lunch will be served, and the amount of food and drinks consumed will be measured (by weight difference before and after serving).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adult
- Aged between 21 - 40 years old
- BMI between 18.0-30.0 kg/m2
- Blood pressure < 140/80 mmHg
- Fasting blood glucose < 6.0mmol/L
- Fasting blood glucose < 6.0mmol/L
Exclusion Criteria:
- Are a smoker
- Have symptoms or medical history of gastrointestinal, cardiovascular, diabetes, cancer or other illnesses/diseases/conditions that could affect gastric motility and appetite
- Are on prescription medication
- Had a major medical or surgical event requiring hospitalization within the preceding 3 months.
- Are taking part in other clinical trials concurrently
- Are taking part in sports at competitive/endurance levels
- Have a score equal or greater than 3.7 for restrained eating in Dutch Eating Behaviour Questionnaire.
- Have special dietary requirements or food allergies.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: No carbonation (control)
No carbonation (NC, control): Potable water + sugar
|
500 ml of beverage consisting of water + 10% glucose and no carbonation
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Active Comparator: Low carbonation
Low carbonation (LC): Potable water + sugar + little CO2
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500 ml of beverage consisting of water + 10% glucose and low carbonation
|
Active Comparator: High carbonation
High carbonation (HC): Potable water + sugar+ high CO2
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500 ml of beverage consisting of water + 10% glucose and high carbonation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in blood glucose concentrations in capillary blood using Hemocue
Time Frame: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
|
Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120 minutes using a Hemocue system (HemoCue Glucose 201 RT Systems)
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0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cross sectional area of antrum imaged using ultrasound
Time Frame: 0, 5, 10, 20, 30, 40, 50, 60, 90, 120 after drinking test beverage
|
Cross sectional area of antrum will be assessed at 0, 15, 30, 45, 60, 90, 120 minutes using ultrasonography.
|
0, 5, 10, 20, 30, 40, 50, 60, 90, 120 after drinking test beverage
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Satiety
Time Frame: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
|
Appetite ratings will be collected at 0, 15, 30, 45, 60, 90, 120 minutes after drinking test beverage using a previously validated visual analog scales [Flint, A., A. Raben, J. E. Blundell and A. Astrup (2000).
"Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies."
International Journal of Obesity 24(1): 38-48]
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0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
|
Amount of food consumed
Time Frame: 2.5 hr subsequent to beverage consumption
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Ad-libitum lunch will be provided 2.5 hours after beverage consumption.
The weight of the foods (g) will be taken before and after consumption, and the difference will be taken to measure the amount of food consumed (g).
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2.5 hr subsequent to beverage consumption
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Energy intake
Time Frame: 2.5 hr subsequent to beverage consumption
|
Ad-libitum lunch will be provided 2.5 hours after beverage consumption.
The energy intake will be calculated from the amount of food consumed (see Outcome 4), as well as the energy content per weight (read off from the nutritional information panel provided on the packaging) to calculate the energy intake (kcal).
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2.5 hr subsequent to beverage consumption
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Collaborators and Investigators
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
- 2015/01079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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