DiabetesNCT02487680
Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism on Healthy Subjects
A study testing Amino Acids and chromium-picolinate containing drink in people with Diabetes, run by DoubleGood AB.
Trial summary
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Amino Acids and chromium-picolinate containing drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable body weight (no changes above 3 kg during the last 2 months)
- Good general health
- Body mass index 19 - 30 kg/m2 (normal to overweight)
- Fasting blood glucose below 6.1 mmol/L
Who cannot join
- Any medication that could influence the study. Such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia
- Psychiatric Disease
- Alcohol or drug abuse
- Smokers or people consuming snus
- Acute infections
- Vegetarians/vegans
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- Suffering from Lactose or Gluten intolerance
- Pregnancy or Lactation
- Participation in another study at the same time
- Any other parameter that the PI will judge as inadequate
About this study
Official title: Effect of a Table Water Enriched With Amino Acids and Chromium on Blood Glucose and Insulin Levels After a Meal
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.
- Conditions
- Diabetes
- Being tested
- Amino Acids and chromium-picolinate containing drink, Placebo drink
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acids and chromium-picolinate containing drinkDietary supplement
Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma
Placebo drinkDietary supplement
Evaluation of the placebo supplement drink containing only aroma
| Study group | Role | What they receive |
|---|---|---|
| Breakfast meal | Experimental | A breakfast like meal will be provided together with a drink to overnight fasted subjects Receives: Dietary Supplement: Amino Acids and chromium-picolinate containing drink; Dietary Supplement: Placebo drink |
| Lunch meal | Experimental | A lunch like meal will be provided together with a drink to overnight fasted subjects Receives: Dietary Supplement: Amino Acids and chromium-picolinate containing drink; Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for Glucose after ingestion of a test meal
Measured: 180 min
Secondary outcomes (1)
Area under the curve for insulin after ingestion of a test meal
Measured: 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DoubleGood AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Per Humpert, MD, Prof, Principal investigator, Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, GermanyAna Rascón, PhD, Prof, Study director, Food for Health Science Center, Lund University, SwedenKristina Andersson, PhD, Study chair, Experimental Medical Science, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487680
- Sponsor's protocol ID
- DoubleGood Lund
- Status last verified
- May 2017
- First submitted
- 29 Jun 2015
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Table Water Enriched With Amino Acids and Chromium on Blood Glucose and Insulin Levels After a Meal
- ClinicalTrials.gov ID
- NCT02487680
- Acronym / sponsor ID
- DoubleGood Lund
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DoubleGood ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Jul 2015 (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.
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast meal | Experimental | Dietary Supplement: Amino Acids and chromium-picolinate containing drink, Dietary Supplement: Placebo drinkA breakfast like meal will be provided together with a drink to overnight fasted subjects |
| Lunch meal | Experimental | Dietary Supplement: Amino Acids and chromium-picolinate containing drink, Dietary Supplement: Placebo drinkA lunch like meal will be provided together with a drink to overnight fasted subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable body weight (no changes above 3 kg during the last 2 months)
- Good general health
- Body mass index 19 - 30 kg/m2 (normal to overweight)
- Fasting blood glucose below 6.1 mmol/L
Key exclusion criteria (10 listed)
- Any medication that could influence the study. Such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia
- Psychiatric Disease
- Alcohol or drug abuse
- Smokers or people consuming snus
- Acute infections
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 |
|---|---|---|
| Amino Acids and chromium-picolinate containing drinkEvaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma | Dietary supplement | Breakfast meal, Lunch meal |
| Placebo drinkEvaluation of the placebo supplement drink containing only aroma | Dietary supplement | Breakfast meal, Lunch meal |
Primary outcome
Area under the curve for Glucose after ingestion of a test meal
Time frame: 180 min
1 secondary outcome
Area under the curve for insulin after ingestion of a test meal
Time frame: 180 min
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 12 May 2017.
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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.
Per Humpert, MD, Prof principal investigator
Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, Germany
Ana Rascón, PhD, Prof study director
Food for Health Science Center, Lund University, Sweden
Kristina Andersson, PhD study chair
Experimental Medical Science, Lund University, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acids and chromium-picolinate containing drink in people with Diabetes, 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 4 inclusion and 10 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 12 May 2017. 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. 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?
Area under the curve for Glucose after ingestion of a test meal (time frame: 180 min). 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 12 May 2017.