Glycemic ResponseNCT02735889
Fizzy Drinks Study
A study testing No Carbonation, Low carbonation and High carbonation in people with Glycemic Response and Gastric Emptying, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response, Gastric Emptying, Satiety
- What is being tested?
- No Carbonation, Low carbonation and High carbonation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Levels of Carbonation in Drinks on Glycemic Response, Gastric Emptying, Satiety and Energy Intake
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.
Read the 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).
- Conditions
- Glycemic Response, Gastric Emptying, Satiety
- Being tested
- No Carbonation, Low carbonation, High carbonation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No CarbonationOther
500 ml of beverage consisting of water + 10% glucose and no carbonation
Low carbonationOther
500 ml of beverage consisting of water + 10% glucose and low carbonation
High carbonationOther
500 ml of beverage consisting of water + 10% glucose and high carbonation
| Study group | Role | What they receive |
|---|---|---|
| No carbonation (control) | Other | No carbonation (NC, control): Potable water + sugar Receives: Other: No Carbonation |
| Low carbonation | Active comparator | Low carbonation (LC): Potable water + sugar + little CO2 Receives: Other: Low carbonation |
| High carbonation | Active comparator | High carbonation (HC): Potable water + sugar+ high CO2 Receives: Other: High carbonation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
Secondary outcomes (4)
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.
Measured: 0, 5, 10, 20, 30, 40, 50, 60, 90, 120 after drinking test beverage
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]
Measured: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
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).
Measured: 2.5 hr subsequent to beverage consumption
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).
Measured: 2.5 hr subsequent to beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735889
- Sponsor's protocol ID
- 2015/01079
- Other IDs
- 2015
- Status last verified
- Nov 2016
- First submitted
- 13 Mar 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Levels of Carbonation in Drinks on Glycemic Response, Gastric Emptying, Satiety and Energy Intake
- ClinicalTrials.gov ID
- NCT02735889
- Acronym / sponsor ID
- 2015/01079
- Conditions
- Glycemic Response, Gastric Emptying, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No carbonation (control) | Other | Other: No CarbonationNo carbonation (NC, control): Potable water + sugar |
| Low carbonation | Active comparator | Other: Low carbonationLow carbonation (LC): Potable water + sugar + little CO2 |
| High carbonation | Active comparator | Other: High carbonationHigh carbonation (HC): Potable water + sugar+ high CO2 |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Carbonation500 ml of beverage consisting of water + 10% glucose and no carbonation | Other | No carbonation (control) |
| Low carbonation500 ml of beverage consisting of water + 10% glucose and low carbonation | Other | Low carbonation |
| High carbonation500 ml of beverage consisting of water + 10% glucose and high carbonation | Other | High carbonation |
Primary outcome
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)
4 secondary outcomes
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
Satiety
Time frame: 0, 15, 30, 45, 60, 90 and 120 min after drinking test beverage
Amount of food consumed
Time frame: 2.5 hr subsequent to beverage consumption
Energy intake
Time frame: 2.5 hr subsequent to beverage consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Carbonation, Low carbonation and High carbonation in people with Glycemic Response and Gastric Emptying, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.