Blood GlucoseNCT03796286
A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses
A study testing Medium-fiber bar and High-fiber bar in people with Blood Glucose and Insulin Sensitivity, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites in United States.
Trial summary
This randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Insulin Sensitivity, Dietary Fiber
- What is being tested?
- Medium-fiber bar and High-fiber bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Dec 2018to 27 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
- Male or female, 18-65 y of age, inclusive.
- Subject has a body mass index of 18.5 to 32.0 kg/m, inclusive.
- Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- Subject is willing to consume the study products as described in the protocol.
- Subject is willing to maintain usual diet and activity patterns throughout the study.
- Subject has no plans to change smoking or other nicotine use during the study period.
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- Subject is willing and able to attend all clinic visits.
- Subject has a vein access scale score of 7-10.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Who cannot join
- Individual has a clinically significant gastrointestinal, endocrine (including Type 1 and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder.
- Subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dL) at screening. One re-test on a separate day will be allowed for subjects with no known history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dL at screening (visit 1).
- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
- Individual has a history of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Individual has extreme dietary habits (e.g., Atkins, vegan).
- Individual has had weight change of ±4.5 kg (10 lbs) in the previous 3 months.
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- Individual has a known allergy, sensitivity, or intolerance to any ingredients in the study products.
- Individual is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Individual has been exposed to any non-registered drug product within 30 days of screening.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MB Clinical Research
Boca Raton, Florida, 33487
Great Lakes Clinical Trials
Chicago, Illinois, 60640
About this study
Official title: A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.
This randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.
- Conditions
- Blood Glucose, Insulin Sensitivity, Dietary Fiber
- Being tested
- Medium-fiber bar, High-fiber bar, Control bar (0 g fiber)
- Keywords
- Postprandial glucose, Meal tolerance test
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-fiber barOther
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
High-fiber barOther
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
Control bar (0 g fiber)Other
Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
| Study group | Role | What they receive |
|---|---|---|
| Control bar (0 g fiber) | Placebo comparator | Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit. Receives: Other: Control bar (0 g fiber) |
| Medium-fiber bar | Experimental | Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit. Receives: Other: Medium-fiber bar |
| High-fiber bar | Experimental | Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit. Receives: Other: High-fiber bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incremental area under the curve for capillary glucose.
Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose.
Measured: Up to 120 minutes - measured at each treatment visit
Secondary outcomes (2)
Change in the incremental area under the curve for venous glucose.
Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.
Measured: Up to 120 minutes - measured at each treatment visit
Change in the incremental area under the curve for venous insulin.
Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous insulin.
Measured: Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start14 Dec 2018
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ingredion Incorporated
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796286
- Sponsor's protocol ID
- MB-1805
- Status last verified
- Jul 2019
- First submitted
- 4 Jan 2019
- Last updated
- 24 Jul 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.
- ClinicalTrials.gov ID
- NCT03796286
- Acronym / sponsor ID
- MB-1805
- Conditions
- Blood Glucose, Insulin Sensitivity, Dietary Fiber
- Keywords
- Postprandial glucose, Meal tolerance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Ingredion Incorporated
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 8 Jan 2019 (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 randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.
| Arm | Type | Receives |
|---|---|---|
| Control bar (0 g fiber) | Placebo comparator | Other: Control bar (0 g fiber)Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit. |
| Medium-fiber bar | Experimental | Other: Medium-fiber barEach subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit. |
| High-fiber bar | Experimental | Other: High-fiber barEach subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 18-65 y of age, inclusive.
- Subject has a body mass index of 18.5 to 32.0 kg/m, inclusive.
- Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- Subject is willing to consume the study products as described in the protocol.
- Subject is willing to maintain usual diet and activity patterns throughout the study.
Key exclusion criteria (10 listed)
- Individual has a clinically significant gastrointestinal, endocrine (including Type 1 and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder.
- Subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dL) at screening. One re-test on a separate day will be allowed for subjects with no known history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dL at screening (visit 1).
- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
- Individual has a history of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Individual has extreme dietary habits (e.g., Atkins, vegan).
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 |
|---|---|---|
| Medium-fiber barEach subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. | Other | Medium-fiber bar |
| High-fiber barEach subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. | Other | High-fiber bar |
| Control bar (0 g fiber)Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber. | Other | Control bar (0 g fiber) |
Primary outcome
Change in the incremental area under the curve for capillary glucose.
Time frame: Up to 120 minutes - measured at each treatment visit
Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose.
2 secondary outcomes
Change in the incremental area under the curve for venous glucose.
Time frame: Up to 120 minutes - measured at each treatment visit
Change in the incremental area under the curve for venous insulin.
Time frame: Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.
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 24 Jul 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.
Kevin Maki, PhD study director
Midwest Biomedical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium-fiber bar and High-fiber bar in people with Blood Glucose and Insulin Sensitivity, run by Midwest Center for Metabolic and Cardiovascular Research at 2 sites 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 9 inclusion and 10 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 the incremental area under the curve for capillary glucose. (time frame: Up to 120 minutes - measured at each treatment visit). 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 24 Jul 2019.