Clinical trial NCT02735889: Fizzy Drinks Study
Official title: The Effect of Different Levels of Carbonation in Drinks on Glycemic Response, Gastric Emptying, Satiety and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Gastric Emptying
Satiety
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2016-04-13
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to compare the effect of different levels of carbonation isocaloric beverages on glycemic response (using protocol based on standardized glycemic index testing methodology), gastric emptying and satiety. It is hypothesized that carbon dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would have important health implications for the beverage industry.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in blood glucose concentrations in capillary blood using Hemocue
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
Secondary outcomes:
measure: Changes in cross sectional area of antrum imaged using ultrasound
timeFrame: 0, 5, 10, 20, 30, 40, 50, 60, 90, 120 after drinking test beverage
measure: Satiety
timeFrame: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
measure: Amount of food consumed
timeFrame: 2.5 hr subsequent to beverage consumption
measure: Energy intake
timeFrame: 2.5 hr subsequent to beverage consumption
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: