Fizzy Drinks Study

NCT ID: NCT02735889

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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).

Conditions

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Glycemic Response Gastric Emptying Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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No carbonation (control)

No carbonation (NC, control): Potable water + sugar

Group Type OTHER

No Carbonation

Intervention Type OTHER

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

Low carbonation

Low carbonation (LC): Potable water + sugar + little CO2

Group Type ACTIVE_COMPARATOR

Low carbonation

Intervention Type OTHER

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

High carbonation

High carbonation (HC): Potable water + sugar+ high CO2

Group Type ACTIVE_COMPARATOR

High carbonation

Intervention Type OTHER

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

Interventions

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No Carbonation

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

Intervention Type OTHER

Low carbonation

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

Intervention Type OTHER

High carbonation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore Institute of Food and Biotechnology Innovation

OTHER_GOV

Sponsor Role lead

Responsible Party

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JeyaKumar Henry

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Nutrition Research Centre

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2015/01079

Identifier Type: -

Identifier Source: org_study_id