DiabetesNCT01275820
A Study to Evaluate Glucose and Insulin Response to Nutralin
An observational study of Diabetes, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels. 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?
- Nutralin
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2010
- Phase
- Observational
- 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
Study population: Individuals in and around the area of Sioux Falls, SD
Who may be able to join
- Men and women who are at least 18 years of age
- Non-diabetic
Who cannot join
- Diabetes
- Women who are pregnant, breastfeeding or planning to become pregnant
- Current and active liver or kidney disease
- Any food allergies
- Celiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.
Read the detailed description
The investigational food product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs using the product. The hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product.
- Conditions
- Diabetes
- Being tested
- Nutralin
- Keywords
- diabetes, insulin, blood sugar
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutralinDietary supplement
Also called No other names at this time.
Food product to be taken 15 minutes prior to each of the three main meals of the day.
| Study group | Role | What they receive |
|---|---|---|
| Nutralin | All 10 subjects in the study will consume the investigational food product. Receives: Dietary Supplement: Nutralin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose blood level
Measure the change in blood sugar levels
Measured: 4 weeks
Secondary outcomes (1)
Dosage of Insulin
Measure the levels of insulin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionSep 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vintek, LLC
- Investigators
- Edward Zawada, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275820
- Sponsor's protocol ID
- ARI-1330-Nutralin
- Status last verified
- Jan 2011
- First submitted
- 10 Jan 2011
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Glucose and Insulin Response to Nutralin
- ClinicalTrials.gov ID
- NCT01275820
- Acronym / sponsor ID
- ARI-1330-Nutralin
- Conditions
- Diabetes
- Keywords
- diabetes, insulin, blood sugar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Collaborators
- Vintek, LLC
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Jan 2011 (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 evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.
Detailed description
The investigational food product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs using the product. The hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutralin | – | Dietary Supplement: NutralinAll 10 subjects in the study will consume the investigational food product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals in and around the area of Sioux Falls, SD
Key inclusion criteria (2 listed)
- Men and women who are at least 18 years of age
- Non-diabetic
Key exclusion criteria (5 listed)
- Diabetes
- Women who are pregnant, breastfeeding or planning to become pregnant
- Current and active liver or kidney disease
- Any food allergies
- Celiac disease
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 |
|---|---|---|
| NutralinAlso: No other names at this time.Food product to be taken 15 minutes prior to each of the three main meals of the day. | Dietary supplement | Nutralin |
Primary outcome
Glucose blood level
Time frame: 4 weeks
Measure the change in blood sugar levels
1 secondary outcome
Dosage of Insulin
Time frame: 4 weeks
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 Jan 2011.
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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.
Edward Zawada, MD principal investigator
Avera McKennan Hospital & University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
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 2 inclusion and 5 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 Jan 2011. 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 United States. 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?
Glucose blood level (time frame: 4 weeks). 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 Jan 2011.