Type2 Diabetes MellitusNCT03334643
Fiber Mix and Glycemic Response
A study testing Fiber mix in people with Type2 Diabetes Mellitus, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study determines the acute effect of a dietary fiber mix on blood glucose levels. Participants will consume the fiber mix as a drink and we will monitor changes in blood glucose levels. All participants will consume white bread as the control food. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Fiber mix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 1 Feb 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Understand and be able to follow written and oral instructions in English
- Provide written informed consent
Who cannot join
- Receiving insulin for diabetes treatment
- Receiving injectable prescription medicine
- Self-reported allergy or intolerance to any ingredients in the test food
- Any conditions deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research that may interfere with study outcomes, at the discretion of the investigators
- Any conditions deemed by the investigators that would compromise the individual's ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Food, Nutrition & Health
New Brunswick, New Jersey, 08901
About this study
Official title: The Effect of a Dietary Fiber Mix on Glycemic Response in Human: a Pilot Study
This study determines the acute effect of a dietary fiber mix on blood glucose levels. Participants will consume the fiber mix as a drink and we will monitor changes in blood glucose levels. All participants will consume white bread as the control food.
Read the detailed description
There is some evidence for increased dietary fiber intake to positively impact on metabolic outcomes in patients with type 2 diabetes, potentially via modulating gut microbial composition and functions. We have developed a dietary fiber mix that is consisted of fiber of various physicochemical properties to maximize the fermentability of the supplement and thus its effects on the gut microbiota. Since the fiber mix also contains nutrients that will raise blood glucose levels, we need to characterize the glycemic response to the fiber mix itself, before we can use it in an upcoming trial to determine the effect of dietary fiber supplementation on the gut microbiota and glycemic control.
Enrolled participants will be assigned to a subject group based on their diagnosis of type 2 diabetes and fasting blood glucose concentrations. Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes will be assigned to the Prediabetes/Diabetes group. For the other participants, those with fasting blood glucose < 100 mg/dL will be assigned to the Non-Diabetes group, and those with fasting blood glucose > 100 mg/dL will be assigned to the Prediabetes/Diabetes group.
Participants will attend 8 food testing visits over 2 weeks. For each visit, participants will attend the research facility in the morning after an overnight fast. They will consume either white bread (with 50 g of available carbohydrates as a control food) or 60 g of the fiber mix (as a drink).
Postprandial glycemic response will be assessed by changes in blood glucose levels, to be monitored using a continuous glucose monitoring system (FreeStyle Pro). A sensor will be placed on the participant's arm and will stay on until the end of the study.
Participants will provide photos of all the food and drink and a brief description of what they have consumed throughout the 2-week study.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Fiber mix
- Keywords
- Type 2 Diabetes, Dietary fiber, Glycemic response
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber mixDietary supplement
Participants will test white bread or fiber mix over a span of 2 weeks. During each testing block, each food will be tested twice over two consecutive days. There are 4 testing blocks in total (one for white bread and three for fiber mix).
| Study group | Role | What they receive |
|---|---|---|
| Non-Diabetes | Experimental | Participants without clinical diagnosis of impaired glucose tolerance or type 2 diabetes and with fasting blood glucose less than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored. Receives: Dietary Supplement: Fiber mix |
| Prediabetes/Diabetes | Experimental | Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes, and those without the above diagnosis but with fasting blood glucose equal to or greater than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored. Receives: Dietary Supplement: Fiber mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Circulating blood glucose concentration will be measured using a continuous glucose monitoring system (FreeStyle Libre Pro, Abbott Diabetes Care)
Measured: The system will measure circulating blood glucose concentrations every 15 min continuously over 14 days. The data collected immediately prior to and up to 3 h after consuming the test food will be used to assess postprandial glycemic response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start4 Jun 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either the Non-Diabetes or Prediabetes/Diabetes group based on their diagnosis of type 2 diabetes (if any) and their fasting blood glucose concentrations.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liping Zhao PhD, Professor, Rutgers, The State University of New Jersey
- Investigators
- Liping Zhao, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334643
- Sponsor's protocol ID
- 18-074m
- Status last verified
- Apr 2019
- First submitted
- 3 Nov 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Dietary Fiber Mix on Glycemic Response in Human: a Pilot Study
- ClinicalTrials.gov ID
- NCT03334643
- Acronym / sponsor ID
- 18-074m
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes, Dietary fiber, Glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 7 Nov 2017 (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.
This study determines the acute effect of a dietary fiber mix on blood glucose levels. Participants will consume the fiber mix as a drink and we will monitor changes in blood glucose levels. All participants will consume white bread as the control food.
Detailed description
There is some evidence for increased dietary fiber intake to positively impact on metabolic outcomes in patients with type 2 diabetes, potentially via modulating gut microbial composition and functions. We have developed a dietary fiber mix that is consisted of fiber of various physicochemical properties to maximize the fermentability of the supplement and thus its effects on the gut microbiota. Since the fiber mix also contains nutrients that will raise blood glucose levels, we need to characterize the glycemic response to the fiber mix itself, before we can use it in an upcoming trial to determine the effect of dietary fiber supplementation on the gut microbiota and glycemic control.
Enrolled participants will be assigned to a subject group based on their diagnosis of type 2 diabetes and fasting blood glucose concentrations. Participants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes will be assigned to the Prediabetes/Diabetes group. For the other participants, those with fasting blood glucose < 100 mg/dL will be assigned to the Non-Diabetes group, and those with fasting blood glucose > 100 mg/dL will be assigned to the Prediabetes/Diabetes group.
Participants will attend 8 food testing visits over 2 weeks. For each visit, participants will attend the research facility in the morning after an overnight fast. They will consume either white bread (with 50 g of available carbohydrates as a control food) or 60 g of the fiber mix (as a drink).
Postprandial glycemic response will be assessed by changes in blood glucose levels, to be monitored using a continuous glucose monitoring system (FreeStyle Pro). A sensor will be placed on the participant's arm and will stay on until the end of the study.
Participants will provide photos of all the food and drink and a brief description of what they have consumed throughout the 2-week study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either the Non-Diabetes or Prediabetes/Diabetes group based on their diagnosis of type 2 diabetes (if any) and their fasting blood glucose concentrations.
| Arm | Type | Receives |
|---|---|---|
| Non-Diabetes | Experimental | Dietary Supplement: Fiber mixParticipants without clinical diagnosis of impaired glucose tolerance or type 2 diabetes and with fasting blood glucose less than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored. |
| Prediabetes/Diabetes | Experimental | Dietary Supplement: Fiber mixParticipants who are clinically diagnosed with impaired glucose tolerance or type 2 diabetes, and those without the above diagnosis but with fasting blood glucose equal to or greater than 100 mg/dL. They will consume white bread or fiber mix for multiple times over a span of 2 weeks. Changes in blood glucose levels will be monitored. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years
- Understand and be able to follow written and oral instructions in English
- Provide written informed consent
Key exclusion criteria (5 listed)
- Receiving insulin for diabetes treatment
- Receiving injectable prescription medicine
- Self-reported allergy or intolerance to any ingredients in the test food
- Any conditions deemed by the investigators that would prevent participation in the study, e.g. participation in past or active clinical research that may interfere with study outcomes, at the discretion of the investigators
- Any conditions deemed by the investigators that would compromise the individual's ability to complete the study, e.g. serious psychiatric conditions, at the discretion of the investigators
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 |
|---|---|---|
| Fiber mixParticipants will test white bread or fiber mix over a span of 2 weeks. During each testing block, each food will be tested twice over two consecutive days. There are 4 testing blocks in total (one for white bread and three for fiber mix). | Dietary supplement | Non-Diabetes, Prediabetes/Diabetes |
Primary outcome
Postprandial glycemic response
Time frame: The system will measure circulating blood glucose concentrations every 15 min continuously over 14 days. The data collected immediately prior to and up to 3 h after consuming the test food will be used to assess postprandial glycemic response
Circulating blood glucose concentration will be measured using a continuous glucose monitoring system (FreeStyle Libre Pro, Abbott Diabetes Care)
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 4 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Liping Zhao, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber mix in people with Type2 Diabetes Mellitus, run by Rutgers, The State University of New Jersey 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: finished, as of the sponsor's last update on 4 Apr 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. 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 glycemic response (time frame: The system will measure circulating blood glucose concentrations every 15 min continuously over 14 days. The data collected immediately prior to and up to 3 h after consuming the test food will be used to assess postprandial glycemic response). 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 4 Apr 2019.