Glycemic ControlNCT04848233
Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans
A study of Glycemic Control and Diet, Food and Nutrition, run by DoubleGood AB at 1 site in Sweden.
Trial summary
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Control, Diet, Food and Nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 20 Apr 2021to 26 May 2021
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-29.9 kg/m^2
- HOMA-IR < 2.5
- Fasting glucose < 6.1 mmol/L
- Stable weight since 3 months
- Access to iPhone with Bluetooth 4.0 and iOS 13 or later
Who cannot join
- Diabetes
- Pharmacological treatment known to interfer with metabolism
- Antibiotics treatment the latest 3 months
- Vegetarian/Vegan diet
- Use of tobacco
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.
- Conditions
- Glycemic Control, Diet, Food and Nutrition
- Being tested
- Drinks containing 5AA+CrPic and Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinks containing 5AA+CrPic and PlaceboDietary supplement
Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Drink intervention | Other | Placebo and two drinks containing a blend of five amino acids and chromium picolinate, are included with every main meal and served in a standardized, non-randomised order. Receives: Dietary Supplement: Drinks containing 5AA+CrPic and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose response
Incremental area under the blood glucose curve after each meal
Measured: From start of meal (0 min) to 120 min postprandially
Secondary outcomes (1)
Glycemic variability
Variation in blood glucose levels
Measured: 24 hour cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 Apr 2021
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycemic ControlStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- DoubleGood AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- starScience GmbH
- Responsible party
- Sponsor
- Investigators
- Elin Ostman, PhD, Principal investigator, Aventure AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848233
- Sponsor's protocol ID
- DG2101_CGM
- Status last verified
- Nov 2022
- First submitted
- 9 Apr 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samigullin A, Humpert PM, Ostman E. Continuous glucose monitoring as a close to real life alternative to meal studies - a pilot study with a functional drink containing amino acids and chromium. Front Med Technol. 2022 Aug 18;4:931837. doi: 10.3389/fmedt.2022.931837. eCollection 2022.
PubMed 36062264
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
- ClinicalTrials.gov ID
- NCT04848233
- Acronym / sponsor ID
- DG2101_CGM
- Conditions
- Glycemic Control, Diet, Food and Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- DoubleGood ABIndustry (pharma, biotech, devices)
- Collaborators
- starScience GmbH
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 19 Apr 2021 (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.
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drink intervention | Other | Dietary Supplement: Drinks containing 5AA+CrPic and PlaceboPlacebo and two drinks containing a blend of five amino acids and chromium picolinate, are included with every main meal and served in a standardized, non-randomised order. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 25-29.9 kg/m^2
- HOMA-IR < 2.5
- Fasting glucose < 6.1 mmol/L
- Stable weight since 3 months
- Access to iPhone with Bluetooth 4.0 and iOS 13 or later
Key exclusion criteria (6 listed)
- Diabetes
- Pharmacological treatment known to interfer with metabolism
- Antibiotics treatment the latest 3 months
- Vegetarian/Vegan diet
- Use of tobacco
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 |
|---|---|---|
| Drinks containing 5AA+CrPic and PlaceboSame diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study. | Dietary supplement | Drink intervention |
Primary outcome
Postprandial glucose response
Time frame: From start of meal (0 min) to 120 min postprandially
Incremental area under the blood glucose curve after each meal
1 secondary outcome
Glycemic variability
Time frame: 24 hour cycles
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 22 Nov 2022.
- Results publication: PubMed 36062264Samigullin A, Humpert PM, Ostman E. Continuous glucose monitoring as a close to real life alternative to meal studies - a pilot study with a functional drink containing amino acids and chromium. Front Med Technol. 2022 Aug 18;4:931837. doi: 10.3389/fmedt.2022.931837. eCollection 2022.
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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 Ostman, PhD principal investigator
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 of Glycemic Control and Diet, Food and Nutrition, 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 5 inclusion and 6 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 22 Nov 2022. 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. 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?
Postprandial glucose response (time frame: From start of meal (0 min) to 120 min postprandially). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848233, which also lists 1 linked publication.
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 22 Nov 2022.