ObesityIODCNCT03630263
This Study Assessed the Impact of Diet on Gastric Emptying Time and Metabolic Flexibility
A study testing Raw Corn Starch and No Raw Corn Starch in people with Obesity and Diabetes Mellitus, Type 2, run by Purdue University at 1 site in United States.
Trial summary
Consumption of slowly digestible carbohydrates can elicit higher satiety feeling compared to rapidly digestible carbohydrates, however not all individuals respond the same. The physiological mechanism that accounts for the satiety effect and the lack of consistency among subjects is not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- What is being tested?
- Raw Corn Starch and No Raw Corn Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Apr 2022
- 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
- BMI 18.5 - 25.0 kg/m2
- 18 - 50 years
- Normal fasting blood glucose
Who cannot join
- History of gastrointestinal disease
- Diabetes
- Pregnant and nursing women
- Wheat and/or gluten allergies or sensitivities
- Allergy to specific sources of slowly digestible carbohydrates
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University Lyles Porter Room 1144
West Lafayette, Indiana, 47907
About this study
Official title: Impact of Diet in Shaping Gastric Response and RER in Adults From Rural Africa and Urban USA
Consumption of slowly digestible carbohydrates can elicit higher satiety feeling compared to rapidly digestible carbohydrates, however not all individuals respond the same. The physiological mechanism that accounts for the satiety effect and the lack of consistency among subjects is not fully understood. The overall aim of this research is to determine if consumption of slow digestible carbohydrates can induce non-responding subjects (i.e., with rapid gastric emptying) to activate the ileal brake and delay rate of gastric emptying.
Read the detailed description
The purpose of this study is to understand how diet may affect carbohydrate digestion, gastric emptying time and overall health. The investigators will be recruiting 32 volunteers for this study. To be eligible for this study, you need to be between 18 and 50 years old, have a normal Body Mass Index, have a normal fasting blood glucose level, be free of any gastrointestinal diseases, diabetes, cardiovascular diseases, be free of wheat allergens, gluten intolerance or sensitivities, and allergy to millet, and not be pregnant or nursing. If you have any questions about the criteria, please ask the person consenting you.
In this study, participants will consume two test meals at different times to assess gastric emptying times. Test meals will consist of either corn starch (30 g) or pregelatinized (DE-1 Maltodextrin) starch in applesauce (200 g) with xanthan gum (0.2 g) to equalize viscosity. Ingredients will be mixed immediately before consumption. For assessment of gastric emptying time, we will use a non-invasive 13C-labeled octanoic acid breath test. In our proposed procedure, 13C octanoic acid will be added to test meals, and breath samples will be taken before and after ingestion up to 4 hours. Breath samples will be collected every 15 minutes for first 2 hours and every 30 minutes for the next 2 hours. Participants will breathe into 300 mL bags and their content will be evaluated for [13C] using a 13CO2 Urea Breath Analyzer POCone (Otsuka Electronics Co, Ltd, Osaka, Japan) as measures of gastric emptying. We have used the labeled substrate and breath collection methods in our lab under previously approved IRB protocols at Purdue University (IRB Protocols #1102010450, #1104010761, #1209012595, #1405014904, and #1502015807, #1611018484, #1706019377. In addition, before, during, and after each session, subjects will also be asked to fill out a short questionnaire with questions regarding your hunger and fullness at those times. Test meals will be prepared in the university with trained personnel. All the ingredients will be purchased from approved food manufacturers.
During testing days participants will be required to stay in the laboratory. Testing day sessions will last about 4 hours. The day prior testing, participants will be provided a standard meal but are not required to stay.
For assessment of diet composition, three 24-hour dietary recalls will be used. Participants will be called on three different days. During these sessions, participants will be asked to recount quantity and types of foods consumed throughout the day, including two weekdays and one weekend day, to form a comprehensive picture of their dietary habits. Dietary data will be collected and stored using no personally identifiable information.
The purpose of this study is to evaluate the continuous effect of slowly digestible carbohydrates consumption on gastric emptying and its potential health benefits.
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- Being tested
- Raw Corn Starch, No Raw Corn Starch
- Keywords
- Gastric emptying, Postprandial blood glucose
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raw Corn StarchOther
Raw corn starch (30 g) will be added to 200 g of applesauce and served to participants, gastric emptying rate, and postprandial glucose will be measured.
No Raw Corn StarchOther
200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Raw Corn Starch | Experimental | Vehicle (apple sauce) will be spiked with 30 g of slowly digestible carbohydrate (raw corn starch) Receives: Other: Raw Corn Starch |
| No Raw Corn Starch | Placebo comparator | Vehicle (apple sauce) will not be spiked with 30 g of slowly digestible carbohydrate (raw corn starch) Receives: Other: No Raw Corn Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
13C octanoid acid labeled
Measured: Acute measurement of gastric emptying (4 hours post test meal consumption)
Metabolic fuel utilization
Measured using RER with Lumen
Measured: Acute measures (2 hours post test meal consumption)
Secondary outcomes (1)
Self reported satiety scores
Hunger and fullness scores using a 10 cm scale (0=weakest feeling of hunger or fullness; 10=highest or strongest feeling of hunger or fullness)
Measured: Acute measurement of satiety or hunger scores (4 hours post test meal consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 May 2019
- Primary completion23 Dec 2021
- Study completion1 Apr 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Repeated measures ANOVA, within factors.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 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
- NCT03630263
- Sponsor's protocol ID
- IRB-2019-206
- Acronym
- IODC
- Status last verified
- Nov 2022
- First submitted
- 9 Aug 2018
- Last updated
- 16 Nov 2022
- 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 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diet in Shaping Gastric Response and RER in Adults From Rural Africa and Urban USA
- ClinicalTrials.gov ID
- NCT03630263
- Acronym / sponsor ID
- IODC / IRB-2019-206
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- Keywords
- Gastric emptying, Postprandial blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 14 Aug 2018 (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.
Consumption of slowly digestible carbohydrates can elicit higher satiety feeling compared to rapidly digestible carbohydrates, however not all individuals respond the same. The physiological mechanism that accounts for the satiety effect and the lack of consistency among subjects is not fully understood. The overall aim of this research is to determine if consumption of slow digestible carbohydrates can induce non-responding subjects (i.e., with rapid gastric emptying) to activate the ileal brake and delay rate of gastric emptying.
Detailed description
The purpose of this study is to understand how diet may affect carbohydrate digestion, gastric emptying time and overall health. The investigators will be recruiting 32 volunteers for this study. To be eligible for this study, you need to be between 18 and 50 years old, have a normal Body Mass Index, have a normal fasting blood glucose level, be free of any gastrointestinal diseases, diabetes, cardiovascular diseases, be free of wheat allergens, gluten intolerance or sensitivities, and allergy to millet, and not be pregnant or nursing. If you have any questions about the criteria, please ask the person consenting you.
In this study, participants will consume two test meals at different times to assess gastric emptying times. Test meals will consist of either corn starch (30 g) or pregelatinized (DE-1 Maltodextrin) starch in applesauce (200 g) with xanthan gum (0.2 g) to equalize viscosity. Ingredients will be mixed immediately before consumption. For assessment of gastric emptying time, we will use a non-invasive 13C-labeled octanoic acid breath test. In our proposed procedure, 13C octanoic acid will be added to test meals, and breath samples will be taken before and after ingestion up to 4 hours. Breath samples will be collected every 15 minutes for first 2 hours and every 30 minutes for the next 2 hours. Participants will breathe into 300 mL bags and their content will be evaluated for [13C] using a 13CO2 Urea Breath Analyzer POCone (Otsuka Electronics Co, Ltd, Osaka, Japan) as measures of gastric emptying. We have used the labeled substrate and breath collection methods in our lab under previously approved IRB protocols at Purdue University (IRB Protocols #1102010450, #1104010761, #1209012595, #1405014904, and #1502015807, #1611018484, #1706019377. In addition, before, during, and after each session, subjects will also be asked to fill out a short questionnaire with questions regarding your hunger and fullness at those times. Test meals will be prepared in the university with trained personnel. All the ingredients will be purchased from approved food manufacturers.
During testing days participants will be required to stay in the laboratory. Testing day sessions will last about 4 hours. The day prior testing, participants will be provided a standard meal but are not required to stay.
For assessment of diet composition, three 24-hour dietary recalls will be used. Participants will be called on three different days. During these sessions, participants will be asked to recount quantity and types of foods consumed throughout the day, including two weekdays and one weekend day, to form a comprehensive picture of their dietary habits. Dietary data will be collected and stored using no personally identifiable information.
The purpose of this study is to evaluate the continuous effect of slowly digestible carbohydrates consumption on gastric emptying and its potential health benefits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Repeated measures ANOVA, within factors.
| Arm | Type | Receives |
|---|---|---|
| Raw Corn Starch | Experimental | Other: Raw Corn StarchVehicle (apple sauce) will be spiked with 30 g of slowly digestible carbohydrate (raw corn starch) |
| No Raw Corn Starch | Placebo comparator | Other: No Raw Corn StarchVehicle (apple sauce) will not be spiked with 30 g of slowly digestible carbohydrate (raw corn starch) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18.5 - 25.0 kg/m2
- 18 - 50 years
- Normal fasting blood glucose
Key exclusion criteria (5 listed)
- History of gastrointestinal disease
- Diabetes
- Pregnant and nursing women
- Wheat and/or gluten allergies or sensitivities
- Allergy to specific sources of slowly digestible carbohydrates
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 |
|---|---|---|
| Raw Corn StarchRaw corn starch (30 g) will be added to 200 g of applesauce and served to participants, gastric emptying rate, and postprandial glucose will be measured. | Other | Raw Corn Starch |
| No Raw Corn Starch200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured. | Other | No Raw Corn Starch |
Primary outcome
Gastric emptying time
Time frame: Acute measurement of gastric emptying (4 hours post test meal consumption)
13C octanoid acid labeled
Metabolic fuel utilization
Time frame: Acute measures (2 hours post test meal consumption)
Measured using RER with Lumen
1 secondary outcome
Self reported satiety scores
Time frame: Acute measurement of satiety or hunger scores (4 hours post test meal 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 16 Nov 2022.
- 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.
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 Raw Corn Starch and No Raw Corn Starch in people with Obesity and Diabetes Mellitus, Type 2, 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 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 16 Nov 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 emptying time (time frame: Acute measurement of gastric emptying (4 hours post test meal consumption)). The study lists 2 primary outcomes in all. 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 16 Nov 2022.