ObesityINTNCT05430061
Crossover Trials Which Assessed Consumption of Slowly Digestible Carbohydrates for 21 Days on Gastric Emptying Rates
A study testing slowly digestible carbohydrate in people with Obesity and Diabetes, run by Purdue University at 1 site in United States.
Trial summary
To gain a better understanding about the conditioning effect of consumption of slowly digestible carbohydrate on gastric emptying rate, respiratory quotient and metabolic flexibility, this study will focus on monitoring change in gastric emptying with consumption of a single source of slowly digestible carbohydrate… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- slowly digestible carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 1 Dec 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal body mass index (18.5 kg/m² < BMI < 25)
- healthy eating index score (<65)
Who cannot join
- gastrointestinal and cardiovascular disease
- food allergies or intolerances
- pregnancy
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rates
To gain a better understanding about the conditioning effect of consumption of slowly digestible carbohydrate on gastric emptying rate, respiratory quotient and metabolic flexibility, this study will focus on monitoring change in gastric emptying with consumption of a single source of slowly digestible carbohydrate (30 g of raw corn starch) for 21 days and compared to a control (21 days of continious consumption of rapidly digesting carbohydrate maltodextrin).
Read the detailed description
Corn starch, a commonly consumed food ingredient, considered GRAS (generally recognized as safe) CFR 182.70- 182.90 will be used as the test meal treatment fed to non-responding subjects (rapid gastric emptying rate after consumption of slowly digestible carbohydrate) for 1 month. Corn starch will be mixed with applesauce (200 g) and a small amount of xanthan gum (amount to be determined) (GRAS # 121) for palatability and viscosity, respectively.
In order to determine whether potential changes in gastric emptying time are induced by consumption of slowly digestible carbohydrates, a control group will be used. The control group will consume a meal composed applesauce (200 g) and xanthan gum with a fast digesting carbohydrate (30 g DE -1 maltodextrinpregelatinized starch). The product is commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. The general term "maltodextrin" is a non-sweet nutritive polymer that consists of D-glucose units linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444).DE-1 Maltodextrin is commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. Maltodextrin is a non-sweet nutritive saccharide polymer that consists of D-glucose units linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444). Ultimately, this study will help elucidate attributes of carbohydrate-based foods that can promote slow digestion and create a satiety feeling and promote weight management, which can then be implemented to develop foods with superior health benefits.
- Being tested
- slowly digestible carbohydrate
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slowly digestible carbohydrateDietary supplement
carbohydrates with slow digestion rate have the capacity to induce slow gastric emptying time and potentially modify metabolic response and modulate postprandial glycemia.
| Study group | Role | What they receive |
|---|---|---|
| Raw corn starch | Experimental | Raw corn starch is a slow digesting carbohydrate, corn starch, a commonly consumed food ingredient, considered GRAS (generally recognized as safe) CFR 182.70- 182.90 will be used as the test meal treatment. Participants will receive 21 individual containers of raw corn starch (30 g/container) and 21 cups of 4 oz unsweetened apple sauce. Participants will be asked to consume one starch container mixed in apple sauce at 10 a.m.; each day for 21 days. Receives: Dietary Supplement: slowly digestible carbohydrate |
| Maltodextrin DE-10 | Sham comparator | Maltodextrin dextrose equivalent 10 is a fast digesting carbohydrate, is a non-sweet nutritive polymer that consists of D-glucose units linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444).DE-1 Maltodextrin is commercially available. Participants will receive 21 individual containers of maltodextrin (30 g/container) and 21 cups of 4 oz unsweetened apple sauce. Participants will be asked to consume one maltodextrin container mixed in apple sauce at 10 a.m.; each day for 21 days. Receives: Dietary Supplement: slowly digestible carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric half emptying time
Using a 13C octanoic acid breath test we assessed gastric emptying time using a non-invasive procedure
Measured: 21 days of intervention
Secondary outcomes (2)
Respiratory exchange ratio and metabolic flexibility
Using a portable, handheld device we assessed CO2 production after a consumption of a standardized meal. This device helped used determine RER and subsequent metabolic flexibility.
Measured: 21 days of intervention
Height and Weight
Height (in cm) and Weight (in Kg) will not be individually collected and will not be an outcome in the study. However, height and weight will be used by the algorithm using by the device (Lumen) to calculate RER. We do not expect to see changes in weight during the intervention.
Measured: Height and weight will only be entered at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start27 Jul 2017
- Primary completion23 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- treatment (21 days of consumption of 30 g of raw corn starch) and control (21 days of consumption of maltodextrin)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
- Investigators
- Bruce R Hamaker, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430061
- Sponsor's protocol ID
- 1706019377
- Acronym
- INT
- Status last verified
- Jun 2022
- First submitted
- 26 Apr 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rates
- ClinicalTrials.gov ID
- NCT05430061
- Acronym / sponsor ID
- INT / 1706019377
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Jun 2022 (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.
To gain a better understanding about the conditioning effect of consumption of slowly digestible carbohydrate on gastric emptying rate, respiratory quotient and metabolic flexibility, this study will focus on monitoring change in gastric emptying with consumption of a single source of slowly digestible carbohydrate (30 g of raw corn starch) for 21 days and compared to a control (21 days of continious consumption of rapidly digesting carbohydrate maltodextrin).
Detailed description
Corn starch, a commonly consumed food ingredient, considered GRAS (generally recognized as safe) CFR 182.70- 182.90 will be used as the test meal treatment fed to non-responding subjects (rapid gastric emptying rate after consumption of slowly digestible carbohydrate) for 1 month. Corn starch will be mixed with applesauce (200 g) and a small amount of xanthan gum (amount to be determined) (GRAS # 121) for palatability and viscosity, respectively.
In order to determine whether potential changes in gastric emptying time are induced by consumption of slowly digestible carbohydrates, a control group will be used. The control group will consume a meal composed applesauce (200 g) and xanthan gum with a fast digesting carbohydrate (30 g DE -1 maltodextrinpregelatinized starch). The product is commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. The general term "maltodextrin" is a non-sweet nutritive polymer that consists of D-glucose units linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444).DE-1 Maltodextrin is commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. Maltodextrin is a non-sweet nutritive saccharide polymer that consists of D-glucose units linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444). Ultimately, this study will help elucidate attributes of carbohydrate-based foods that can promote slow digestion and create a satiety feeling and promote weight management, which can then be implemented to develop foods with superior health benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- treatment (21 days of consumption of 30 g of raw corn starch) and control (21 days of consumption of maltodextrin)
| Arm | Type | Receives |
|---|---|---|
| Raw corn starch | Experimental | Dietary Supplement: slowly digestible carbohydrateRaw corn starch is a slow digesting carbohydrate, corn starch, a commonly consumed food ingredient, considered GRAS (generally recognized as safe) CFR 182.70- 182.90 will be used as the test meal treatment. Participants will receive 21 individual containers of raw corn starch (30 g/container) and 21 cups of 4 oz unsweetened apple sauce. Participants will be asked to consume one starch container mixed in apple sauce at 10 a.m.; each day for 21 days. |
| Maltodextrin DE-10 | Sham comparator | Dietary Supplement: slowly digestible carbohydrateMaltodextrin dextrose equivalent 10 is a fast digesting carbohydrate, is a non-sweet nutritive polymer that consists of D-glucose units linked primarily by [alpha]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444).DE-1 Maltodextrin is commercially available. Participants will receive 21 individual containers of maltodextrin (30 g/container) and 21 cups of 4 oz unsweetened apple sauce. Participants will be asked to consume one maltodextrin container mixed in apple sauce at 10 a.m.; each day for 21 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal body mass index (18.5 kg/m² < BMI < 25)
- healthy eating index score (<65)
Key exclusion criteria (4 listed)
- gastrointestinal and cardiovascular disease
- food allergies or intolerances
- pregnancy
- smokers
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 |
|---|---|---|
| slowly digestible carbohydratecarbohydrates with slow digestion rate have the capacity to induce slow gastric emptying time and potentially modify metabolic response and modulate postprandial glycemia. | Dietary supplement | Maltodextrin DE-10, Raw corn starch |
Primary outcome
Gastric half emptying time
Time frame: 21 days of intervention
Using a 13C octanoic acid breath test we assessed gastric emptying time using a non-invasive procedure
2 secondary outcomes
Respiratory exchange ratio and metabolic flexibility
Time frame: 21 days of intervention
Height and Weight
Time frame: Height and weight will only be entered at baseline.
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 Jun 2022.
- Individual participant dataSharing planned: No. No data sharing
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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.
Bruce R Hamaker, PhD principal investigator
Purdue 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 slowly digestible carbohydrate in people with Obesity and Diabetes, run by Purdue University 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 2 inclusion and 4 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 Jun 2022. 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?
Gastric half emptying time (time frame: 21 days of intervention). 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 Jun 2022.