Postprandial HyperglycemiaNCT03552315
Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.
A study testing Carbonated water with amino acids and chromium in people with Postprandial Hyperglycemia and Metabolic Syndrome, run by DoubleGood AB at 1 site in Sweden.
Trial summary
It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Metabolic Syndrome, Type 2 Diabetes Mellitus
- What is being tested?
- Carbonated water with amino acids and chromium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2018to 5 Sep 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 to 50 years of age
- BMI 25-29.9 (±0.5) kg/m²
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
- Healthy as determined by medical history and information provided by the volunteer
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Elevated fasting blood glucose (at or above 6.1 mmol/L)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the qualified investigator (QI). Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
Show all 17Show fewer
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, placebo or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to lactose or gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
- Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover, Single-center, Proof of Concept Study to Evaluate the Efficacy of GoodIdea® on Glucose Homeostasis in a Healthy Population.
It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.
- Being tested
- Carbonated water with amino acids and chromium, Placebo Carbonated Water
- Medical subject headings
- Hyperglycemia, Metabolic Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbonated water with amino acids and chromiumDietary supplement
The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
Placebo Carbonated WaterDietary supplement
The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
| Study group | Role | What they receive |
|---|---|---|
| Water with amino acids and chromium | Active comparator | The carbonated water with a proprietary blend of five amino acids and chromium picolinate is consumed with a standardized test meal to study its effects on glucose and insulin responses. Receives: Dietary Supplement: Carbonated water with amino acids and chromium |
| Carbonated water | Placebo comparator | The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses. Receives: Dietary Supplement: Placebo Carbonated Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
The incremental area under the curve for capillary blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
Measured: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Secondary outcomes (3)
The three-hour iAUC for insulin, 0-180 minutes
The incremental area under the curve for intravenous blood insulin will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
Measured: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The three hour iAUC for intravenous glucose, 0-180 minutes
The incremental area under the curve for intravenous blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
Measured: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes
The incremental area under the curve for intravenous blood GLP-1 will be measured within 60 minutes after a test meal. Blood samples will be collected at 5 time points during the 60 minutes.
Measured: 0, 15, 30, 45 and 60 minutes post test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start24 Apr 2018
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- DoubleGood AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Kristina E Andersson, PhD, Principal investigator, Lund University and Aventure AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552315
- Sponsor's protocol ID
- DG1802
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover, Single-center, Proof of Concept Study to Evaluate the Efficacy of GoodIdea® on Glucose Homeostasis in a Healthy Population.
- ClinicalTrials.gov ID
- NCT03552315
- Acronym / sponsor ID
- DG1802
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- DoubleGood ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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.
It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water with amino acids and chromium | Active comparator | Dietary Supplement: Carbonated water with amino acids and chromiumThe carbonated water with a proprietary blend of five amino acids and chromium picolinate is consumed with a standardized test meal to study its effects on glucose and insulin responses. |
| Carbonated water | Placebo comparator | Dietary Supplement: Placebo Carbonated WaterThe placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female 18 to 50 years of age
- BMI 25-29.9 (±0.5) kg/m²
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
- Healthy as determined by medical history and information provided by the volunteer
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
Key exclusion criteria (17 listed)
- Elevated fasting blood glucose (at or above 6.1 mmol/L)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the qualified investigator (QI). Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
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 |
|---|---|---|
| Carbonated water with amino acids and chromiumThe active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes | Dietary supplement | Water with amino acids and chromium |
| Placebo Carbonated WaterThe placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes | Dietary supplement | Carbonated water |
Primary outcome
The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The incremental area under the curve for capillary blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
3 secondary outcomes
The three-hour iAUC for insulin, 0-180 minutes
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The three hour iAUC for intravenous glucose, 0-180 minutes
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes
Time frame: 0, 15, 30, 45 and 60 minutes post test meal
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 4 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Postprandial Hyperglycemia
Active, not recruiting
How Fig Polyphenols Affect Blood Sugar and Insulin Levels After Eating in Adults at Risk for Diabetes
Pre Diabetic
Enrolling by invitation
Development of Anti-Diabetic Nutraceuticals From Legume Seed Coats
Postprandial Hyperglycemia, Type 2 Diabetes
Active, not recruiting
Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults
Postprandial Hyperglycemia, Hyperinsulinemia
Recruiting
Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring
Postprandial Glucose, Glucose Levels
Not yet recruiting
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (Prediabetes)
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.
Kristina E Andersson, PhD principal investigator
Lund University and Aventure AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbonated water with amino acids and chromium in people with Postprandial Hyperglycemia and Metabolic Syndrome, run by DoubleGood AB at 1 site in Sweden.
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 17 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 4 Sep 2019. 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 Sweden. 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. 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?
The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes (time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal). 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 4 Sep 2019.