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Completed

NCT Number: NCT02735889

Fizzy Drinks Study

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.

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Key information

Conditions

Glycemic Response Gastric Emptying Satiety

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre

Singapore, 117599

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Carbonation

Other

500 ml of beverage consisting of water + 10% glucose and no carbonation

Low carbonation

Other

500 ml of beverage consisting of water + 10% glucose and low carbonation

High carbonation

Other

500 ml of beverage consisting of water + 10% glucose and high carbonation

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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]

  3. Amount of food consumed

    Time frame: 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 13, 2016
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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