DiabetesPhase 2NCT01275027
A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
A Phase 2 study testing Nutralin in people with Diabetes, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Nutralin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2011
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women who are at least 18 years old
- Diagnosis of Type 2 Diabetes
- Has been on stable diabetes medication/insulin for the past three months
Who cannot join
- Women who are pregnant, breastfeeding or planning to become pregnant
- Diagnosis of Celiac Disease or gluten intolerance
- Current or active kidney disease
- Current or active liver disease
- Any food allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.
Read the detailed description
The investigational 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 consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.
The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.
- Conditions
- Diabetes
- Being tested
- Nutralin
- Keywords
- diabetes, blood sugar, insulin, nutritional supplement, nutraceutical
- 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
7 capsules taken 15 minutes before each of the three main meals of the day
| Study group | Role | What they receive |
|---|---|---|
| Nutralin | Experimental | Individuals with Type 2 Diabetes Receives: Dietary Supplement: Nutralin |
| Placebo | Placebo comparator | Individuals with Type 2 Diabetes Receives: Dietary Supplement: Nutralin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugar
blood sugar levels
Measured: 16 weeks
HgA1c reduction
reduction of Hemoglobin A1c levels
Measured: 16 weeks
Secondary outcomes (1)
Diabetes medication
reduction in the amount of diabetes medication needed
Measured: 16 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 startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Sponsor recalled the study
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Zawada, MD, Principal investigator, Avera McKennan Hospital & University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275027
- Sponsor's protocol ID
- ARI-1340-Nutralin
- Status last verified
- Apr 2015
- First submitted
- 10 Jan 2011
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
- ClinicalTrials.gov ID
- NCT01275027
- Acronym / sponsor ID
- ARI-1340-Nutralin
- Conditions
- Diabetes
- Keywords
- diabetes, blood sugar, insulin, nutritional supplement, nutraceutical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor recalled the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (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 clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.
Detailed description
The investigational 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 consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.
The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutralin | Experimental | Dietary Supplement: NutralinIndividuals with Type 2 Diabetes |
| Placebo | Placebo comparator | Dietary Supplement: NutralinIndividuals with Type 2 Diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women who are at least 18 years old
- Diagnosis of Type 2 Diabetes
- Has been on stable diabetes medication/insulin for the past three months
Key exclusion criteria (5 listed)
- Women who are pregnant, breastfeeding or planning to become pregnant
- Diagnosis of Celiac Disease or gluten intolerance
- Current or active kidney disease
- Current or active liver disease
- Any food allergies
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 |
|---|---|---|
| Nutralin7 capsules taken 15 minutes before each of the three main meals of the day | Dietary supplement | Nutralin, Placebo |
Primary outcome
Blood Sugar
Time frame: 16 weeks
blood sugar levels
HgA1c reduction
Time frame: 16 weeks
reduction of Hemoglobin A1c levels
1 secondary outcome
Diabetes medication
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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?
A Phase 2 study testing Nutralin in people with 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 3 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Sugar (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 22 Apr 2015.