Fizzy Drinks Study

Not Applicable

Completed

• Conditions: Glycemic Response; Gastric Emptying; Satiety
• Interventions: Other: No Carbonation; Other: Low carbonation; Other: High carbonation

• Registration Number: NCT02735889
• Lead Sponsor: Clinical Nutrition Research Centre, Singapore

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).

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-03-13
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No carbonation (control)	No Carbonation	No carbonation (NC, control): Potable water + sugar
Low carbonation	Low carbonation	Low carbonation (LC): Potable water + sugar + little CO2
High carbonation	High carbonation	High carbonation (HC): Potable water + sugar+ high CO2

Primary Outcome Measures

Name	Time	Method
Changes in blood glucose concentrations in capillary blood using Hemocue	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)

Secondary Outcome Measures

Name	Time	Method
Satiety	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 \[Flint, A., A. Raben, J. E. Blundell and A. Astrup (2000). "Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies." International Journal of Obesity 24(1): 38-48\]
Amount of food consumed	2.5 hr subsequent to beverage consumption	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).
Energy intake	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).
Changes in cross sectional area of antrum imaged using ultrasound	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.

Trial Locations

Locations (1)

Clinical Nutrition Research Centre; 🇸🇬 Singapore, Singapore