ObesityNCT03630445
Slowly Digestible Carbohydrates and the Ileal Brake
A study testing Isomaltooligosaccharides (IMOs), Xtend® sucromalt and Combination of IMOs and Xtend® sucromalt in people with Obesity and Diabetes Mellitus, Type 2, run by Purdue University at 1 site in United States.
Trial summary
The ileal brake is a feedback mechanism controlling stomach-mediated transit of a meal, for which gastric emptying can be used as an indicator. Previously, slowly digestible carbohydrates (SDCs) were shown to activate the ileal brake in a rat model; the current research aimed to determine the effect of common SDCs in… 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?
- Isomaltooligosaccharides (IMOs), Xtend® sucromalt and Combination of IMOs and Xtend® sucromalt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2015to 31 Jul 2015
- 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 kg/m2
- Stable weight for the past 3 months (i.e. +/- 2..5 kg)
- Regular eating patterns, including breakfast consumption
Who cannot join
- Gastrointestinal disease
- Smokers
- Peri- or post-menopausal women
- Celiac disease (yogurts may contain ingredients with wheat origin)
- Allergies, including dairy, lactose, and gluten
- Pregnant and lactating women
Show all 12Show fewer
- Following a weight reduction program or having followed one during the last 3 months
- Acute or chronic disease
- Alcohol consumption > 30 units/week
- Hypertension
- Diabetes
- Previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response
The ileal brake is a feedback mechanism controlling stomach-mediated transit of a meal, for which gastric emptying can be used as an indicator. Previously, slowly digestible carbohydrates (SDCs) were shown to activate the ileal brake in a rat model; the current research aimed to determine the effect of common SDCs in humans.
Read the detailed description
Diets containing slowly digestible carbohydrates (SDCs), in the form of starch-entrapped microspheres that digest into the ileum, were previously shown to reduce food intake in a diet-induced obese rat model by activating the gut-brain axis. These results suggested that SDCs trigger the ileal brake, which is a feedback mechanism controlling stomach-mediated transit of a meal. The ileal brake is characterized by delayed gastric emptying rate and increased satiety. The goal of this work was to determine if common SDCs trigger the ileal brake in humans, using gastric emptying rate as a proxy indicator. In a human study, SDCs were delivered through a semi-solid yogurt matrix, and gastric half-emptying time and postprandial glycemic response were assessed. The study was a five-arm, double-blind, crossover design with a one-week washout period between treatments (n=20, 9 females, 11 males). Four different carbohydrate ingredients (SDCs: isomalto-oligosaccharides (IMO), Xtend® sucromalt, and raw corn starch; and non-SDC: maltodextrin) were incorporated individually, or in combination, into yogurt products matched in energy density and viscosity. Participants consumed 300 g test meals of yogurt formulated with one or a combination of the carbohydrate ingredients after an overnight fast. Gastric emptying rates and glycemic response were measured using a 13C-labeled octanoic acid breath test and continuous glucose monitors, respectively. Glucose readings were continuously monitored 24 h prior to and 48 h after test meal consumption, and breath samples were collected for a 4 h period following test meal consumption.
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- Being tested
- Isomaltooligosaccharides (IMOs), Xtend® sucromalt, Combination of IMOs and Xtend® sucromalt, Raw corn starch, Maltodextrin
- 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.
Isomaltooligosaccharides (IMOs)Other
Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Xtend® sucromaltOther
Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Combination of IMOs and Xtend® sucromaltOther
A combination of IMOs and Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
Raw corn starchOther
Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
MaltodextrinOther
Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
| Study group | Role | What they receive |
|---|---|---|
| Isomaltooligosaccharides (IMOs) | Experimental | Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal.
IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property. Receives: Other: Isomaltooligosaccharides (IMOs) |
| Xtend® sucromalt | Experimental | Xtend® sucromalt incorporated into a yogurt test meal.
Sucromalt is derived from a combination of sucrose (cane or beet sugar) and maltose (corn sugar), yet it has been found to be slowly digested. Receives: Other: Xtend® sucromalt |
| Combination of IMOs and Xtend® sucromalt | Experimental | Combination of IMOs and Xtend® sucromalt incorporated into a yogurt test meal. Receives: Other: Combination of IMOs and Xtend® sucromalt |
| Raw corn starch | Experimental | Raw corn starch incorporated into a yogurt test meal.
Raw corn starch is uncooked starch from corn. Because it is not cooked, it has a slow digestion property. Receives: Other: Raw corn starch |
| Maltodextrin | Experimental | Maltodextrin incorporated into a yogurt test meal.
Maltodextrin is a type of starchy carbohydrate (polysaccharide) composed of units of D-glucose (simple sugars). The maltodextrin used for this study had a fast digestion property. Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying rate
Breath test was performed using 13C-octanoic acid mixed into test meals
Measured: Acute study; 4 hours of measurement after consumption of test food
Glycemic response
Blood glucose was measured using a continuous glucose monitor
Measured: Acute study; 4 hours of measurement after consumption of test food
Appetite ratings (Visual Analog Scale, VAS)
Hunger and fullness scores were measured using a 10-cm scale (0 = weakest feeling of hunger or fullness and 10 = strongest feeling of hunger or fullness) after consumption of test food. Weaker feelings of hunger and stronger feelings of fullness indicate better outcomes.
Measured: Acute study; 4 hours of measurement after consumption of test food
Secondary outcomes (1)
Breath hydrogen (fermentability)
Breath samples were collected in 15-minute intervals for 4 hours after consumption of test food and analyzed for hydrogen levels using a breath analyzer. Breath hydrogen levels are indicative of a food's fermentability.
Measured: Acute study; 4 hours of measurement after consumption of test food
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 start2 Jun 2015
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
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 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630445
- Sponsor's protocol ID
- 1502015807
- Status last verified
- Mar 2021
- First submitted
- 27 Jun 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers
Publications
Chegeni M, Hayes AMR, Gonzalez TD, Manderfeld MM, Lim J, Menon RS, Holschuh NM, Hedges ME, Hamaker BR. Activation of gastrointestinal ileal brake response with dietary slowly digestible carbohydrates, with no observed effect on subjective appetite, in an acute randomized, double-blind, crossover trial. Eur J Nutr. 2022 Jun;61(4):1965-1980. doi: 10.1007/s00394-021-02770-2. Epub 2022 Jan 26.
PubMed 35079895
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Slowly Digestible Carbohydrates on Gastric Emptying Rate Suggests Activation of Ileal Brake Response
- ClinicalTrials.gov ID
- NCT03630445
- Acronym / sponsor ID
- 1502015807
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (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.
The ileal brake is a feedback mechanism controlling stomach-mediated transit of a meal, for which gastric emptying can be used as an indicator. Previously, slowly digestible carbohydrates (SDCs) were shown to activate the ileal brake in a rat model; the current research aimed to determine the effect of common SDCs in humans.
Detailed description
Diets containing slowly digestible carbohydrates (SDCs), in the form of starch-entrapped microspheres that digest into the ileum, were previously shown to reduce food intake in a diet-induced obese rat model by activating the gut-brain axis. These results suggested that SDCs trigger the ileal brake, which is a feedback mechanism controlling stomach-mediated transit of a meal. The ileal brake is characterized by delayed gastric emptying rate and increased satiety. The goal of this work was to determine if common SDCs trigger the ileal brake in humans, using gastric emptying rate as a proxy indicator. In a human study, SDCs were delivered through a semi-solid yogurt matrix, and gastric half-emptying time and postprandial glycemic response were assessed. The study was a five-arm, double-blind, crossover design with a one-week washout period between treatments (n=20, 9 females, 11 males). Four different carbohydrate ingredients (SDCs: isomalto-oligosaccharides (IMO), Xtend® sucromalt, and raw corn starch; and non-SDC: maltodextrin) were incorporated individually, or in combination, into yogurt products matched in energy density and viscosity. Participants consumed 300 g test meals of yogurt formulated with one or a combination of the carbohydrate ingredients after an overnight fast. Gastric emptying rates and glycemic response were measured using a 13C-labeled octanoic acid breath test and continuous glucose monitors, respectively. Glucose readings were continuously monitored 24 h prior to and 48 h after test meal consumption, and breath samples were collected for a 4 h period following test meal consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Isomaltooligosaccharides (IMOs) | Experimental | Other: Isomaltooligosaccharides (IMOs)Isomaltooligosaccharides (IMOs) incorporated into a yogurt test meal. IMOs are a mixture of short-chain carbohydrates with a purported slow digestion property. |
| Xtend® sucromalt | Experimental | Other: Xtend® sucromaltXtend® sucromalt incorporated into a yogurt test meal. Sucromalt is derived from a combination of sucrose (cane or beet sugar) and maltose (corn sugar), yet it has been found to be slowly digested. |
| Combination of IMOs and Xtend® sucromalt | Experimental | Other: Combination of IMOs and Xtend® sucromaltCombination of IMOs and Xtend® sucromalt incorporated into a yogurt test meal. |
| Raw corn starch | Experimental | Other: Raw corn starchRaw corn starch incorporated into a yogurt test meal. Raw corn starch is uncooked starch from corn. Because it is not cooked, it has a slow digestion property. |
| Maltodextrin | Experimental | Other: MaltodextrinMaltodextrin incorporated into a yogurt test meal. Maltodextrin is a type of starchy carbohydrate (polysaccharide) composed of units of D-glucose (simple sugars). The maltodextrin used for this study had a fast digestion property. |
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 kg/m2
- Stable weight for the past 3 months (i.e. +/- 2..5 kg)
- Regular eating patterns, including breakfast consumption
Key exclusion criteria (12 listed)
- Gastrointestinal disease
- Smokers
- Peri- or post-menopausal women
- Celiac disease (yogurts may contain ingredients with wheat origin)
- Allergies, including dairy, lactose, and gluten
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 |
|---|---|---|
| Isomaltooligosaccharides (IMOs)Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability. | Other | Isomaltooligosaccharides (IMOs) |
| Xtend® sucromaltXtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability. | Other | Xtend® sucromalt |
| Combination of IMOs and Xtend® sucromaltA combination of IMOs and Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability. | Other | Combination of IMOs and Xtend® sucromalt |
| Raw corn starchRaw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability. | Other | Raw corn starch |
| MaltodextrinMaltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability. | Other | Maltodextrin |
Primary outcome
Gastric emptying rate
Time frame: Acute study; 4 hours of measurement after consumption of test food
Breath test was performed using 13C-octanoic acid mixed into test meals
Glycemic response
Time frame: Acute study; 4 hours of measurement after consumption of test food
Blood glucose was measured using a continuous glucose monitor
Appetite ratings (Visual Analog Scale, VAS)
Time frame: Acute study; 4 hours of measurement after consumption of test food
Hunger and fullness scores were measured using a 10-cm scale (0 = weakest feeling of hunger or fullness and 10 = strongest feeling of hunger or fullness) after consumption of test food. Weaker feelings of hunger and stronger feelings of fullness indicate better outcomes.
1 secondary outcome
Breath hydrogen (fermentability)
Time frame: Acute study; 4 hours of measurement after consumption of test food
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 10 Mar 2021.
- Derived from this study: PubMed 35079895Chegeni M, Hayes AMR, Gonzalez TD, Manderfeld MM, Lim J, Menon RS, Holschuh NM, Hedges ME, Hamaker BR. Activation of gastrointestinal ileal brake response with dietary slowly digestible carbohydrates, with no observed effect on subjective appetite, in an acute randomized, double-blind, crossover trial. Eur J Nutr. 2022 Jun;61(4):1965-1980. doi: 10.1007/s00394-021-02770-2. Epub 2022 Jan 26.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltooligosaccharides (IMOs), Xtend® sucromalt and Combination of IMOs and Xtend® sucromalt 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 12 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 10 Mar 2021. 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. 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 rate (time frame: Acute study; 4 hours of measurement after consumption of test food). The study lists 3 primary outcomes in all. 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 NCT03630445, 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 10 Mar 2021.