Glucose, High BloodNCT03252704
Post-prandial Glycemic Response to Fiber in Healthy Adults
A study testing resistant starch (high fiber muffin top) in people with Glucose, High Blood and Glucose, Low Blood, run by Ingredion Incorporated.
Trial summary
This randomized, double-blind, comparator controlled trial evaluated the blood glucose and insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, High Blood, Glucose, Low Blood, Meals
- What is being tested?
- resistant starch (high fiber muffin top)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2016to 31 Oct 2016
- 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
- 18 years of age or older,
- BMI 18.0-29.9 kg/m2,
- fasting glucose ≤ 6.0 mmol/L;
- if female, not of childbearing potential (e.g. taking oral contraceptives, past hysterectomy)
Who cannot join
- diagnosed metabolic or chronic diseases (e.g. type-2 diabetes);
- cancer diagnosis or treatment within 5 years;
- gastrointestinal problems;
- bowel cleansing during prior week;
- current medications to control blood glucose;
- current medications to control blood cholesterol ;
Show all 13Show fewer
- current medications to control blood pressure;
- smoker;
- use of medical marijuana;
- alcohol or drug abuse treatment in past 12 months;
- allergy or sensitivity to study products;
- blood donation in prior 2 months;
- if female, currently pregnant, currently breastfeeding, or planning to become pregnant
About this study
Official title: Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults
This randomized, double-blind, comparator controlled trial evaluated the blood glucose and insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.
Read the detailed description
The fiber administered in this trial is a resistant starch type 4 derived from high-amylose maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC 2009.01 method) and can be used in a variety of bakery applications. The objective of this study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a randomized, double-blind, crossover study. The muffin tops were matched for total weight, total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the following morning. Serum glucose, serum insulin, and capillary glucose were measured after muffin top consumption. The subjects completed a seven day washout between treatments.
- Conditions
- Glucose, High Blood, Glucose, Low Blood, Meals
- Being tested
- resistant starch (high fiber muffin top), control (low fiber muffin top)
- Keywords
- postprandial glucose insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistant starch (high fiber muffin top)Other
Muffin top contained 11 g of fiber per portion
control (low fiber muffin top)Other
Muffin top contained 1 g of fiber per portion
| Study group | Role | What they receive |
|---|---|---|
| High fiber - low fiber | Experimental | Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top) Receives: Other: resistant starch (high fiber muffin top); Other: control (low fiber muffin top) |
| low fiber - high fiber | Experimental | Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top) Receives: Other: resistant starch (high fiber muffin top); Other: control (low fiber muffin top) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response
IV and capillary
Measured: 0-4 hours after consumption
Secondary outcomes (2)
Blood insulin response
IV
Measured: 0-4 hours after consumption
Breath hydrogen response
Expired air
Measured: 0-24 hours after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start31 Mar 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose, High BloodStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredion Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Synergize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252704
- Sponsor's protocol ID
- 16AFHI
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart ML, Zimmer JP. Postprandial glucose and insulin response to a high-fiber muffin top containing resistant starch type 4 in healthy adults: a double-blind, randomized, controlled trial. Nutrition. 2018 Sep;53:59-63. doi: 10.1016/j.nut.2018.01.002. Epub 2018 Feb 13.
PubMed 29655779
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults
- ClinicalTrials.gov ID
- NCT03252704
- Acronym / sponsor ID
- 16AFHI
- Conditions
- Glucose, High Blood, Glucose, Low Blood, Meals
- Keywords
- postprandial glucose insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ingredion IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 17 Aug 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 randomized, double-blind, comparator controlled trial evaluated the blood glucose and insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.
Detailed description
The fiber administered in this trial is a resistant starch type 4 derived from high-amylose maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC 2009.01 method) and can be used in a variety of bakery applications. The objective of this study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a randomized, double-blind, crossover study. The muffin tops were matched for total weight, total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the following morning. Serum glucose, serum insulin, and capillary glucose were measured after muffin top consumption. The subjects completed a seven day washout between treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fiber - low fiber | Experimental | Other: resistant starch (high fiber muffin top), Other: control (low fiber muffin top)Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top) |
| low fiber - high fiber | Experimental | Other: resistant starch (high fiber muffin top), Other: control (low fiber muffin top)Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- BMI 18.0-29.9 kg/m2,
- fasting glucose ≤ 6.0 mmol/L;
- if female, not of childbearing potential (e.g. taking oral contraceptives, past hysterectomy)
Key exclusion criteria (13 listed)
- diagnosed metabolic or chronic diseases (e.g. type-2 diabetes);
- cancer diagnosis or treatment within 5 years;
- gastrointestinal problems;
- bowel cleansing during prior week;
- current medications to control blood glucose;
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 |
|---|---|---|
| resistant starch (high fiber muffin top)Muffin top contained 11 g of fiber per portion | Other | High fiber - low fiber, low fiber - high fiber |
| control (low fiber muffin top)Muffin top contained 1 g of fiber per portion | Other | High fiber - low fiber, low fiber - high fiber |
Primary outcome
Blood glucose response
Time frame: 0-4 hours after consumption
IV and capillary
2 secondary outcomes
Blood insulin response
Time frame: 0-4 hours after consumption
Breath hydrogen response
Time frame: 0-24 hours after consumption
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 21 Aug 2017.
- Derived from this study: PubMed 29655779Stewart ML, Zimmer JP. Postprandial glucose and insulin response to a high-fiber muffin top containing resistant starch type 4 in healthy adults: a double-blind, randomized, controlled trial. Nutrition. 2018 Sep;53:59-63. doi: 10.1016/j.nut.2018.01.002. Epub 2018 Feb 13.
- 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.
Tetyana Pelipyagina, MD principal investigator
KGK Synergize
Questions about this trial
What is this clinical trial studying?
A study testing resistant starch (high fiber muffin top) in people with Glucose, High Blood and Glucose, Low Blood, run by Ingredion Incorporated.
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 4 inclusion and 13 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood glucose response (time frame: 0-4 hours after consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252704, which also lists 1 linked publication.
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 21 Aug 2017.