PrediabetesNCT02720393
Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
A study testing No-carrageenan diet and Regular Diet in people with Prediabetes, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- No-carrageenan diet and Regular Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- per diabetes, ability to follow diet and study procedures
Who cannot join
- on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes
Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.
Read the detailed description
Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.
- Conditions
- Prediabetes
- Being tested
- No-carrageenan diet, Regular Diet
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-carrageenan dietOther
Diet of food items that have no carrageenan as selected by study dietician.
Regular DietOther
Also called Carrageenan-containing diet
Diet of food items that have carrageenan as selected by study dietician
| Study group | Role | What they receive |
|---|---|---|
| Regular diet | Placebo comparator | Meals and snacks will contain carrageenan in the amount consumed in the typical daily diet and will be selected by the study dietician and distributed to study subjects randomized to the regular diet study arm. Receives: Other: Regular Diet |
| No-carrageenan diet | Experimental | No-carrageenan diet will be composed of meals and snacks selected by the study dietician and distributed to study participants who are randomized to the no-carrageenan diet study arm. Receives: Other: No-carrageenan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c
Measurements performed after 12 weeks of dietary intervention
Measured: baseline, 12 weeks
Secondary outcomes (6)
Change in serum Interleukin-8
Impact of diet on serum Interleukin-8
Measured: baseline, 12 weeks
Impact on glucose tolerance test
perform repeat oral glucose tolerance test after 12 weeks of dietary intervention
Measured: 12 weeks
Impact on insulin level
determine effect of dietary intervention on insulin level at the time of glucose tolerance test
Measured: 12 weeks
Change in leukocyte subsets
determine if there is change in distribution of leukocyte subsets from blood samples of study participants
Measured: baseline, 12 weeks
Change in Tumor Necrosis Factor-alpha in serum
determine if there is change in circulating TNF-alpha in blood samples
Measured: baseline, 12 weeks
Change in insulin signaling pathway
determine if there are changes in activation of intermediates in insulin signaling pathway in circulating leukocytes following dietary intervention
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Kramer Tobacman, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720393
- Sponsor's protocol ID
- 2015-1255
- Status last verified
- Sep 2019
- First submitted
- 9 Feb 2016
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: If required, individual data without identifiers may be made available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes
- ClinicalTrials.gov ID
- NCT02720393
- Acronym / sponsor ID
- 2015-1255
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Mar 2016 (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.
Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.
Detailed description
Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular diet | Placebo comparator | Other: Regular DietMeals and snacks will contain carrageenan in the amount consumed in the typical daily diet and will be selected by the study dietician and distributed to study subjects randomized to the regular diet study arm. |
| No-carrageenan diet | Experimental | Other: No-carrageenan dietNo-carrageenan diet will be composed of meals and snacks selected by the study dietician and distributed to study participants who are randomized to the no-carrageenan diet study arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- per diabetes, ability to follow diet and study procedures
Key exclusion criteria (1 listed)
- on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
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 |
|---|---|---|
| No-carrageenan dietDiet of food items that have no carrageenan as selected by study dietician. | Other | No-carrageenan diet |
| Regular DietAlso: Carrageenan-containing dietDiet of food items that have carrageenan as selected by study dietician | Other | Regular diet |
Primary outcome
Change in hemoglobin A1c
Time frame: baseline, 12 weeks
Measurements performed after 12 weeks of dietary intervention
6 secondary outcomes
Change in serum Interleukin-8
Time frame: baseline, 12 weeks
Impact on glucose tolerance test
Time frame: 12 weeks
Impact on insulin level
Time frame: 12 weeks
Change in leukocyte subsets
Time frame: baseline, 12 weeks
Change in Tumor Necrosis Factor-alpha in serum
Time frame: baseline, 12 weeks
Change in insulin signaling pathway
Time frame: baseline, 12 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 30 Sep 2019.
- Individual participant dataSharing planned: Undecided. If required, individual data without identifiers may be made available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No-carrageenan diet and Regular Diet in people with Prediabetes, run by University of Illinois Chicago 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 1 inclusion and 1 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 30 Sep 2019. 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.
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?
Change in hemoglobin A1c (time frame: baseline, 12 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 30 Sep 2019.