Fizzy Drinks Study

Gastric Emptying Clinical Trial

Official title:

The Effect of Different Levels of Carbonation in Drinks on Glycemic Response, Gastric Emptying, Satiety and Energy Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735889
• Other study ID #: 2015/01079
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: November 4, 2016
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Gastric Emptying
• Glycemic Response
• Satiety

Intervention

Other:
• No Carbonation
500 ml of beverage consisting of water + 10% glucose and no carbonation
• Low carbonation
500 ml of beverage consisting of water + 10% glucose and low carbonation
• High carbonation
500 ml of beverage consisting of water + 10% glucose and high carbonation

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood glucose concentrations in capillary blood using Hemocue	Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120 minutes using a Hemocue system (HemoCue Glucose 201 RT Systems)	0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage	No
Secondary	Changes in cross sectional area of antrum imaged using ultrasound	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	No
Secondary	Satiety	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]	0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage	No
Secondary	Amount of food consumed	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).	2.5 hr subsequent to beverage consumption	No
Secondary	Energy intake	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).	2.5 hr subsequent to beverage consumption	No