HealthyNCT03411395
Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
A study testing 5AA+CrPic Water in people with Healthy, run by DoubleGood AB.
Trial summary
It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 5AA+CrPic Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2016to 20 Dec 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 18-25 (±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
- Pregnancy or lactation
- Known Type I or Type II diabetes
- Undetected Type I or Type II diabetes (fasting blood glucose < 6.1 mmol/L at first test day)
- Use of antibiotics
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to test product or placebo ingredients
Show all 17Show fewer
- Participants restricted to a vegetarian or vegan diet
- Intolerance to lactose or gluten
- Acute infection
- Individuals who are averse to venous catheterization or capillary blood sampling
- Alcohol or drug abuse
- Currently active smokers (tobacco products, and e-cigarettes)
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the PI'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
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the PI
- 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 PI. 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.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) within 180 minutes after ingestion of the meal.
- Conditions
- Healthy
- Being tested
- 5AA+CrPic Water, Placebo drink
- Keywords
- Diabetes, Prediabetes, Blood sugar regulation
- Medical subject headings
- Diabetes Mellitus, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5AA+CrPic WaterDietary supplement
Also called Good Idea
Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate
Placebo drinkOther
Placebo water with carbonation and aroma
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | A standardized breakfast meal will be provided together with carbonated water containing aroma Receives: Other: Placebo drink |
| 5AA+CrPic Water Dose 1 | Experimental | A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic Receives: Dietary Supplement: 5AA+CrPic Water |
| 5AA+CrPic Water Dose 2 | Experimental | A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic Receives: Dietary Supplement: 5AA+CrPic Water |
| 5AA+CrPic Water Dose 3 | Experimental | A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic Receives: Dietary Supplement: 5AA+CrPic Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response
The difference in three-hour incremental area under the curve (AUC) for capillary blood glucose between 5AA+CrPic test products and placebo following a standardized breakfast meal.
Measured: 3h postprandial phase
Secondary outcomes (5)
Cmax of capillary blood glucose
The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between 5AA+CrPic test products and the placebo following a standardized meal.
Measured: 3h postprandial phase
Serum insulin response
The difference of the three-hour iAUC (0 - 180 min) intravenous serum insulin iAUC between 5AA+CrPic test products and the placebo following a standardized meal.
Measured: 3h postprandial phase
Venous blood glucose response
The difference of the three-hour iAUC (0 - 180 min) intravenous plasma glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal.
Measured: 3h postprandial phase
GLP-1 response
The difference of the 1h iAUC (0 - 60 min) intravenous blood glucagon-like peptide 1 (GLP-1) iAUC between 5AA+CrPic test products and the placebo following a standardized meal.
Measured: 1h postprandial phase
Capillary blood glucose response
The difference in the two-hour iAUC (0 - 120 min) capillary blood glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal.
Measured: 2h postprandial phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start13 Oct 2016
- Primary completion20 Dec 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- DoubleGood AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University, Aventure AB
- Responsible party
- Sponsor
- Investigators
- Elin Östman, PhD, Principal investigator, Scheelevägen 22 223 63 Lund, SwedenKristina Andersson, PhD, Study director, Experimental Medical Science, Lund University, SwedenLovisa Heyman-Lindén, PhD, Study chair, Scheelevägen 22 223 63 Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411395
- Sponsor's protocol ID
- DG1603Lund
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
- ClinicalTrials.gov ID
- NCT03411395
- Acronym / sponsor ID
- DG1603Lund
- Conditions
- Healthy
- Keywords
- Diabetes, Prediabetes, Blood sugar regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- DoubleGood ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University, Aventure AB
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 26 Jan 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 that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Other: Placebo drinkA standardized breakfast meal will be provided together with carbonated water containing aroma |
| 5AA+CrPic Water Dose 1 | Experimental | Dietary Supplement: 5AA+CrPic WaterA standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic |
| 5AA+CrPic Water Dose 2 | Experimental | Dietary Supplement: 5AA+CrPic WaterA standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic |
| 5AA+CrPic Water Dose 3 | Experimental | Dietary Supplement: 5AA+CrPic WaterA standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index 18-25 (±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
Key exclusion criteria (17 listed)
- Pregnancy or lactation
- Known Type I or Type II diabetes
- Undetected Type I or Type II diabetes (fasting blood glucose < 6.1 mmol/L at first test day)
- Use of antibiotics
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
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 |
|---|---|---|
| 5AA+CrPic WaterAlso: Good IdeaDietary supplement drink with carbonation, aroma, amino acids and chromium picolinate | Dietary supplement | 5AA+CrPic Water Dose 1, 5AA+CrPic Water Dose 2, 5AA+CrPic Water Dose 3 |
| Placebo drinkPlacebo water with carbonation and aroma | Other | Placebo drink |
Primary outcome
Blood glucose response
Time frame: 3h postprandial phase
The difference in three-hour incremental area under the curve (AUC) for capillary blood glucose between 5AA+CrPic test products and placebo following a standardized breakfast meal.
5 secondary outcomes
Cmax of capillary blood glucose
Time frame: 3h postprandial phase
Serum insulin response
Time frame: 3h postprandial phase
Venous blood glucose response
Time frame: 3h postprandial phase
GLP-1 response
Time frame: 1h postprandial phase
Capillary blood glucose response
Time frame: 2h postprandial phase
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 26 Jan 2018.
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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.
Elin Östman, PhD principal investigator
Scheelevägen 22 223 63 Lund, Sweden
Kristina Andersson, PhD study director
Experimental Medical Science, Lund University, Sweden
Lovisa Heyman-Lindén, PhD study chair
Scheelevägen 22 223 63 Lund, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing 5AA+CrPic Water in people with Healthy, run by DoubleGood AB.
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 5 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 26 Jan 2018. 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?
Blood glucose response (time frame: 3h postprandial phase). 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 26 Jan 2018.