Glycaemic IndexNCT01536847
Glycaemic Response Testing
A study testing Dietary Intervention in people with Glycaemic Index and Glycaemic Response, run by Mondelēz International, Inc..
Trial summary
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycaemic Index, Glycaemic Response
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jan 2012
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (not less than 40% males or females
- Non-smoker
- Aged 18 to 55 years
- Have a body mass index between 18.5 to 29.99 kg/m2
- Healthy, non-diabetic, no gastric bypass surgery
- Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L)
- Willing and able to provide written informed consent
Who cannot join
None listed.
About this study
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
- Conditions
- Glycaemic Index, Glycaemic Response
- Being tested
- Dietary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
300 ml of liquid food product
Dietary InterventionOther
300 mL of liquid food product
Dietary InterventionOther
300 ml of liquid food product
| Study group | Role | What they receive |
|---|---|---|
| Control Test Drink | Placebo comparator | Control drink Receives: Other: Dietary Intervention |
| Experimental Test Drink 1 | Experimental | Control drink containing ingredient 1 Receives: Other: Dietary Intervention |
| Experimental Test Drink 2 | Experimental | Control drink containing ingredient 2 Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic index of experimental test food using capillary blood
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycaemic IndexStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Responsible party
- Sponsor
- Investigators
- Suzana Louth, Dr, Principal investigator, RSSL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536847
- Sponsor's protocol ID
- P11-09257
- Status last verified
- Sep 2012
- First submitted
- 16 Feb 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Response Testing
- ClinicalTrials.gov ID
- NCT01536847
- Acronym / sponsor ID
- P11-09257
- Conditions
- Glycaemic Index, Glycaemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Reading Scientific Services Ltd.
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Feb 2012 (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 purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Test Drink | Placebo comparator | Other: Dietary InterventionControl drink |
| Experimental Test Drink 1 | Experimental | Other: Dietary InterventionControl drink containing ingredient 1 |
| Experimental Test Drink 2 | Experimental | Other: Dietary InterventionControl drink containing ingredient 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female (not less than 40% males or females
- Non-smoker
- Aged 18 to 55 years
- Have a body mass index between 18.5 to 29.99 kg/m2
- Healthy, non-diabetic, no gastric bypass surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dietary Intervention300 ml of liquid food product | Other | Control Test Drink |
| Dietary Intervention300 mL of liquid food product | Other | Experimental Test Drink 1 |
| Dietary Intervention300 ml of liquid food product | Other | Experimental Test Drink 2 |
Primary outcome
Glycaemic index of experimental test food using capillary blood
Time frame: 0-120 minutes
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 10 Sep 2012.
Related trials for Glycaemic Index
Not yet recruiting
Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition
Prediabetes / Type 2 Diabetes
Not yet recruiting
Impact of a Targeted Nutritional Intervention on Glycaemic Variability and Correlation Between Glycaemic Parameters and Satiety.
Obesity in Adolescents
Not yet recruiting
Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes
Prediabetes
Not yet recruiting
Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants
Healthy Participants
Recruiting
Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.
Late-perimenopause, Menopause
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.
Suzana Louth, Dr principal investigator
RSSL
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Glycaemic Index and Glycaemic Response, run by Mondelēz International, Inc..
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 7 inclusion and 0 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Glycaemic index of experimental test food using capillary blood (time frame: 0-120 minutes). 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 10 Sep 2012.