HealthyRSNCT03844503
Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response
A study testing Cereal Bar no fiber, Cereal bar with 10 g fiber and Cereal bar with 20 g fiber in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cereal Bar no fiber, Cereal bar with 10 g fiber and Cereal bar with 20 g fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 25 Oct 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a male or female, 20-45 years of age, inclusive.
- Subject has a BMI of 20.0-24.9 kg/m2, inclusive and weight ≥ 110 lb. at screening visit.
- Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
- Subject is willing to follow study instructions including compliance with dietary restrictions, consumption of study bars, and study visit schedule.
- Subject is judged to be in good health on the basis of the medical history.
- Subject is willing to abstain from alcohol consumption for 24 hours prior to study visit.
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- Exercise to be maintained throughout study duration, including 3 days before study visit
- Subject is willing to maintain a stable dose of current vitamins, minerals, supplements and medications not interfering with study outcomes, including birth control, throughout the study duration.
- 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/s and is willing to complete study procedures.
Who cannot join
- Subject has fasting finger prick glucose >100 mg/dL.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
- Subject has had major trauma or a surgical event within 2 months of study visit 1.
- Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (i.e. liposuction, laser fat removal, etc)
- Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
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- Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
- Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Subject has a known intolerance or sensitivity to any ingredients in the study products.
- Subject has used medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 1 and throughout the study.
- Subjects who used fiber supplements.
- Subject taking systemic steroids, extreme alcohol use, or drug user.
- Subject has vein access score less than 7.
- Subject is a female, who is pregnant, planning to be pregnant during the study period or lactating.
- Subject is a current smoker. Past smoker abstinence for less than 2 years.
- Subject has participated in any clinical trial within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Food Prototype Containing Resistant Starch Type 4 on Postprandial Glycemic Response in Healthy Adults
The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC, glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of glucose and insulin, and glucose and insulin concentrations at each time point (C max).
Read the detailed description
This is a single-center randomized, single-blinded, cross-over design study to allow for three acute evaluations of 2 hr postprandial glucose in response to 3 cereal bars containing different amounts of resistant starch. The study will evaluate acute glucose and insulin response in healthy men and women aged 20-45 years.
The trial will initiate with record collection to assess background general health (screening visit) and dietary intake followed by counseling to follow a relatively low polyphenolic beverages/foods diet, and high fiber containing food (particularly fermentable) which will commence at least 3 days before randomization (washout) and continue for the duration of the study. After 3-day washout period, subjects will be randomized to treatment order within Phase (Treatment cereal bars A, B, C). Glucose and insulin responses following the consumption of cereal bars will be determined by blood collections via venous catheter. Blood samples (3 ml of blood) will be collected at -5 min (before the cereal bar consumption) and 15, 30, 45, 60, 90, and 120 min after consuming bars for assessment in changes in glucose and insulin concentrations in the plasma. The primary endpoint is glucose positive incremental area under the curve (positive iAUC- ignores area below fasting) among the three tests bars. Secondary endpoints are glucose peak, insulin positive iAUC and peak and glucose and insulin net incremental AUC (net iAUC). Adverse events also will be collected and frequency tabulated.
- Conditions
- Healthy
- Being tested
- Cereal Bar no fiber, Cereal bar with 10 g fiber, Cereal bar with 20 g fiber
- Keywords
- Cereal bar, Fiber, Resistant Starch, Glycemic Response, Insulin Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal Bar no fiberDietary supplement
Cereal Bar no fiber
Cereal bar with 10 g fiberDietary supplement
Cereal bar with 10 g fiber
Cereal bar with 20 g fiberDietary supplement
Cereal bar with 20 g fiber
| Study group | Role | What they receive |
|---|---|---|
| Cereal Bar no fiber | Placebo comparator | Cereal bar without fiber Receives: Dietary Supplement: Cereal Bar no fiber |
| Cereal bar with 10 g fiber | Active comparator | Cereal bar with 10 g fiber Receives: Dietary Supplement: Cereal bar with 10 g fiber |
| Cereal bar with 20 g fiber | Active comparator | Cereal bar with 20 g fiber Receives: Dietary Supplement: Cereal bar with 20 g fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Plasma Glucose concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours
Changes in plasma glucose concentration as measured by positive iAUC (ignoring area below fasting) over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment
Measured: Postprandial 2 hours
Secondary outcomes (6)
Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatments compared to control treatment
Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment
Measured: Postprandial 2 hours
Changes in Plasma Insulin concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours
Changes in Plasma Insulin concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours
Measured: Postprandial 2 hours
Plasma Glucose maximal concentration (Cmax) over 2 hours
Plasma Glucose maximal concentration (Cmax) over 2 hours
Measured: Postprandial 2 hours
Plasma Insulin maximal concentration (Cmax) over 2 hours
Plasma Insulin maximal concentration (Cmax) over 2 hours
Measured: Postprandial 2 hours
Change in postprandial blood glucose concentration responses for treatments compared to control over 2-hour postprandial period
postprandial blood glucose concentration responses over 2 hours
Measured: Postprandial 2 hours
Change in postprandial blood insulin concentration responses for treatments compared to control over 2-hour postprandial period
postprandial blood insulin concentration responses over 2 hours
Measured: Postprandial 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start11 Feb 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844503
- Sponsor's protocol ID
- IRB2019-005
- Acronym
- RS
- Status last verified
- Jul 2020
- First submitted
- 5 Feb 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Prototype Containing Resistant Starch Type 4 on Postprandial Glycemic Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT03844503
- Acronym / sponsor ID
- RS / IRB2019-005
- Conditions
- Healthy
- Keywords
- Cereal bar, Fiber, Resistant Starch, Glycemic Response, Insulin Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 18 Feb 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.
The primary objective of the study is to determine if resistant starch reduces the 2 hour glycemic response as measured by positive incremental area under the blood glucose response curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC, glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of glucose and insulin, and glucose and insulin concentrations at each time point (C max).
Detailed description
This is a single-center randomized, single-blinded, cross-over design study to allow for three acute evaluations of 2 hr postprandial glucose in response to 3 cereal bars containing different amounts of resistant starch. The study will evaluate acute glucose and insulin response in healthy men and women aged 20-45 years.
The trial will initiate with record collection to assess background general health (screening visit) and dietary intake followed by counseling to follow a relatively low polyphenolic beverages/foods diet, and high fiber containing food (particularly fermentable) which will commence at least 3 days before randomization (washout) and continue for the duration of the study. After 3-day washout period, subjects will be randomized to treatment order within Phase (Treatment cereal bars A, B, C). Glucose and insulin responses following the consumption of cereal bars will be determined by blood collections via venous catheter. Blood samples (3 ml of blood) will be collected at -5 min (before the cereal bar consumption) and 15, 30, 45, 60, 90, and 120 min after consuming bars for assessment in changes in glucose and insulin concentrations in the plasma. The primary endpoint is glucose positive incremental area under the curve (positive iAUC- ignores area below fasting) among the three tests bars. Secondary endpoints are glucose peak, insulin positive iAUC and peak and glucose and insulin net incremental AUC (net iAUC). Adverse events also will be collected and frequency tabulated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cereal Bar no fiber | Placebo comparator | Dietary Supplement: Cereal Bar no fiberCereal bar without fiber |
| Cereal bar with 10 g fiber | Active comparator | Dietary Supplement: Cereal bar with 10 g fiberCereal bar with 10 g fiber |
| Cereal bar with 20 g fiber | Active comparator | Dietary Supplement: Cereal bar with 20 g fiberCereal bar with 20 g fiber |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is a male or female, 20-45 years of age, inclusive.
- Subject has a BMI of 20.0-24.9 kg/m2, inclusive and weight ≥ 110 lb. at screening visit.
- Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
- Subject is willing to follow study instructions including compliance with dietary restrictions, consumption of study bars, and study visit schedule.
- Subject is judged to be in good health on the basis of the medical history.
Key exclusion criteria (16 listed)
- Subject has fasting finger prick glucose >100 mg/dL.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
- Subject has had major trauma or a surgical event within 2 months of study visit 1.
- Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (i.e. liposuction, laser fat removal, etc)
- Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
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 |
|---|---|---|
| Cereal Bar no fiberCereal Bar no fiber | Dietary supplement | Cereal Bar no fiber |
| Cereal bar with 10 g fiberCereal bar with 10 g fiber | Dietary supplement | Cereal bar with 10 g fiber |
| Cereal bar with 20 g fiberCereal bar with 20 g fiber | Dietary supplement | Cereal bar with 20 g fiber |
Primary outcome
Changes in Plasma Glucose concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours
Time frame: Postprandial 2 hours
Changes in plasma glucose concentration as measured by positive iAUC (ignoring area below fasting) over a 2 hour Postprandial Test day after administration of active treatment compared to control treatment
6 secondary outcomes
Changes in plasma insulin concentration as measured by iAUC over a 2 hour Postprandial Test day after administration of active treatments compared to control treatment
Time frame: Postprandial 2 hours
Changes in Plasma Insulin concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours
Time frame: Postprandial 2 hours
Plasma Glucose maximal concentration (Cmax) over 2 hours
Time frame: Postprandial 2 hours
Plasma Insulin maximal concentration (Cmax) over 2 hours
Time frame: Postprandial 2 hours
Change in postprandial blood glucose concentration responses for treatments compared to control over 2-hour postprandial period
Time frame: Postprandial 2 hours
Change in postprandial blood insulin concentration responses for treatments compared to control over 2-hour postprandial period
Time frame: Postprandial 2 hours
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 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereal Bar no fiber, Cereal bar with 10 g fiber and Cereal bar with 20 g fiber in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 9 inclusion and 16 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 14 Jul 2020. 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?
Changes in Plasma Glucose concentration as measured by positive incremental area under the curve (positive iAUC) over 2 hours (time frame: Postprandial 2 hours). 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 14 Jul 2020.