Gastric EmptyingNCT03982836
Impact of Different Dietary Fibers in Gastric Emptying Time and Intestinal Transit of Healthy Volunteers
A study testing Soluble Dietary Fibers in people with Gastric Emptying and Intestinal Transit Time, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The digestive process begins in the mouth and follows in the stomach and intestine. In the stomach the food is mixed with the gastric juices forming the chyme. To mix the food with the gastric juice as well as to provide gastric emptying (GE), the movements of the stomach are of great importance. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Intestinal Transit Time
- What is being tested?
- Soluble Dietary Fibers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jul 2018to 30 Sep 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers;
- Both sexes;
- Age Range:From 18 to 40 years old
- Volunteers who do not have gluten or egg restriction
- No history or diagnosis of gastrointestinal diseases;
- Had not undergone recent operations that compromised intestinal transit time and / or gastric emptying.
Who cannot join
- Volunteers who used prebiotic, probiotic and / or symbiotic volunteers at least 10 days prior to study day;
- Volunteers diagnosed with hypothyroidism and / or diabetes or who reported hypoglycemia and not tolerance to fasting;
- Women were asked about pregnancy, suspected pregnancy, use of contraceptive methods and menstrual cycle. If there was any possibility of pregnancy, based on these questions, the volunteer was excluded from the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Enfermagem - UFMG
Belo Horizonte, Minas Gerais, 30130-100
About this study
The digestive process begins in the mouth and follows in the stomach and intestine. In the stomach the food is mixed with the gastric juices forming the chyme. To mix the food with the gastric juice as well as to provide gastric emptying (GE), the movements of the stomach are of great importance. Intestinal transit time is understood of the combination of GE, small intestine transit and colon transit time. The composition of the diet (lipid and protein content) exerts a direct influence on intestinal transit time due to the stimulation of hormone secretion, cholecystokinin and gastrin, respectively, which act to decrease GE velocity. In this context, it is also observed an important influence of dietary fibers on the speed of GE. Despite all knowledge about dietary fibers, information on such compounds still has many controversies. Due to the difficulty of finding compounds that fit into only one specific category (viscous, fermentable or prebiotic) there is difficulty in establishing a concept that best defines what are dietary fibers. The CODEX Alimentarius Commission in 2009 defined dietary fibers as carbohydrate polymers composed of ten or more monomer units of this macronutrient, which are not hydrolyzed by enzymes in the human intestine. Dietary fibers can be classified into insoluble and soluble according to the ability to bind to water molecules and form gels. Soluble fibers, especially those classified as prebiotic, in the intestine are fermented by bacteria giving rise to short chain fatty acids (SCFA). The SCFA stimulates the production and secretion of PYY and GLP-1 are associated with inhibition of gastric motility. Due to the importance of knowing the intestinal transit time, several methods have been developed, but scintigraphy is the gold standard technique for this analysis. Given the above and controversies present in the literature on the dietary fibers, there was a shortage of studies with the objective of evaluating the impact of different dietary fibers in intestinal transit time. This study shows relevant to help elucidate the behavior of different dietary fibers in intestinal transit time, offering data for correct and safe use of dietary fibers in various clinical situations. The hypothesis of this study is that the partially hydrolyzed guar gum delays the time of gastric emptying and intestinal transit, being this effect not observed for fructooligosaccharide
- Conditions
- Gastric Emptying, Intestinal Transit Time
- Being tested
- Soluble Dietary Fibers
- Keywords
- Gastric Emptying, Scintigraphy, Intestinal Transit Time, Prebiotic, Soluble Dietary Fiber, Technetium-99m
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Dietary FibersDietary supplement
Also called Prebiotic, Partially hydrolyzed guar gum
All 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body.
| Study group | Role | What they receive |
|---|---|---|
| Fructooligosaccharide | Experimental | All the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide Receives: Dietary Supplement: Soluble Dietary Fibers |
| Partially hydrolyzed guar gum | Experimental | All the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum Receives: Dietary Supplement: Soluble Dietary Fibers |
| Maltodextrin | Placebo comparator | All the 25 volunteers received the sandwich containing 20 grams of Maltodextrin Receives: Dietary Supplement: Soluble Dietary Fibers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying Time and intestinal transit time
The impact of the fibers under the gastric emptying and intestinal transit time is evaluated after the volunteer performs the ingestion of the 3 modules on different days.
Measured: After the 3rd day of the protocol
Secondary outcomes (2)
Intestinal Hormones Concentrations
Dosage of serum concentrations
Measured: Up to 3 weeks after protocol termination
Compare gastric emptying and intestinal transit times between dietary fiber types
To compare how the fibers influenced the time of gastric emptying and intestinal transit
Measured: Up to 3 weeks after protocol termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start21 Jul 2018
- Primary completion13 Apr 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Model description
- It is a cross-sectional study, where the volunteer should attend the study area on three different days with a minimum washout of 7 days, each day receiving a sandwich containing one of the modules studied in a randomized manner (Partially Hydrolyzed Guar Gum, Fructooligosaccharide or Maltodextrin) and will be instructed to ingest this sandwich in the maximum time of 10 minutes. The volunteers should on an 8-hour fast. Samples of blood will be collected in the fasting, 60 and 180 minutes after the injection of the sandwich for intestinal hormone dosage.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Simone V Generoso, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982836
- Sponsor's protocol ID
- CAAE: 85797918.1.0000.5149
- Status last verified
- Sep 2025
- First submitted
- 21 May 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Dietary Fibers in Gastric Emptying Time and Intestinal Transit of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03982836
- Acronym / sponsor ID
- CAAE: 85797918.1.0000.5149
- Conditions
- Gastric Emptying, Intestinal Transit Time
- Keywords
- Gastric Emptying, Scintigraphy, Intestinal Transit Time, Prebiotic, Soluble Dietary Fiber, Technetium-99m
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 13 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 12 Jun 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 digestive process begins in the mouth and follows in the stomach and intestine. In the stomach the food is mixed with the gastric juices forming the chyme. To mix the food with the gastric juice as well as to provide gastric emptying (GE), the movements of the stomach are of great importance. Intestinal transit time is understood of the combination of GE, small intestine transit and colon transit time. The composition of the diet (lipid and protein content) exerts a direct influence on intestinal transit time due to the stimulation of hormone secretion, cholecystokinin and gastrin, respectively, which act to decrease GE velocity. In this context, it is also observed an important influence of dietary fibers on the speed of GE. Despite all knowledge about dietary fibers, information on such compounds still has many controversies. Due to the difficulty of finding compounds that fit into only one specific category (viscous, fermentable or prebiotic) there is difficulty in establishing a concept that best defines what are dietary fibers. The CODEX Alimentarius Commission in 2009 defined dietary fibers as carbohydrate polymers composed of ten or more monomer units of this macronutrient, which are not hydrolyzed by enzymes in the human intestine. Dietary fibers can be classified into insoluble and soluble according to the ability to bind to water molecules and form gels. Soluble fibers, especially those classified as prebiotic, in the intestine are fermented by bacteria giving rise to short chain fatty acids (SCFA). The SCFA stimulates the production and secretion of PYY and GLP-1 are associated with inhibition of gastric motility. Due to the importance of knowing the intestinal transit time, several methods have been developed, but scintigraphy is the gold standard technique for this analysis. Given the above and controversies present in the literature on the dietary fibers, there was a shortage of studies with the objective of evaluating the impact of different dietary fibers in intestinal transit time. This study shows relevant to help elucidate the behavior of different dietary fibers in intestinal transit time, offering data for correct and safe use of dietary fibers in various clinical situations. The hypothesis of this study is that the partially hydrolyzed guar gum delays the time of gastric emptying and intestinal transit, being this effect not observed for fructooligosaccharide
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- It is a cross-sectional study, where the volunteer should attend the study area on three different days with a minimum washout of 7 days, each day receiving a sandwich containing one of the modules studied in a randomized manner (Partially Hydrolyzed Guar Gum, Fructooligosaccharide or Maltodextrin) and will be instructed to ingest this sandwich in the maximum time of 10 minutes. The volunteers should on an 8-hour fast. Samples of blood will be collected in the fasting, 60 and 180 minutes after the injection of the sandwich for intestinal hormone dosage.
| Arm | Type | Receives |
|---|---|---|
| Fructooligosaccharide | Experimental | Dietary Supplement: Soluble Dietary FibersAll the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide |
| Partially hydrolyzed guar gum | Experimental | Dietary Supplement: Soluble Dietary FibersAll the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum |
| Maltodextrin | Placebo comparator | Dietary Supplement: Soluble Dietary FibersAll the 25 volunteers received the sandwich containing 20 grams of Maltodextrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers;
- Both sexes;
- Age Range:From 18 to 40 years old
- Volunteers who do not have gluten or egg restriction
- No history or diagnosis of gastrointestinal diseases;
Key exclusion criteria (3 listed)
- Volunteers who used prebiotic, probiotic and / or symbiotic volunteers at least 10 days prior to study day;
- Volunteers diagnosed with hypothyroidism and / or diabetes or who reported hypoglycemia and not tolerance to fasting;
- Women were asked about pregnancy, suspected pregnancy, use of contraceptive methods and menstrual cycle. If there was any possibility of pregnancy, based on these questions, the volunteer was excluded from the study.
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 |
|---|---|---|
| Soluble Dietary FibersAlso: Prebiotic, Partially hydrolyzed guar gumAll 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body. | Dietary supplement | Fructooligosaccharide, Maltodextrin, Partially hydrolyzed guar gum |
Primary outcome
Gastric Emptying Time and intestinal transit time
Time frame: After the 3rd day of the protocol
The impact of the fibers under the gastric emptying and intestinal transit time is evaluated after the volunteer performs the ingestion of the 3 modules on different days.
2 secondary outcomes
Intestinal Hormones Concentrations
Time frame: Up to 3 weeks after protocol termination
Compare gastric emptying and intestinal transit times between dietary fiber types
Time frame: Up to 3 weeks after protocol termination
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 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Gastric Emptying
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
Not yet recruitingObservational study
Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
Obesity / Overweight
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Not yet recruiting
Gastric Emptying After a Yoghurt Breakfast in Children: a Pilot Study
Preoperative Fasting
Recruiting
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Depression, Epilepsy
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.
Simone V Generoso principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble Dietary Fibers in people with Gastric Emptying and Intestinal Transit Time, run by Federal University of Minas Gerais at 1 site in Brazil.
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 6 inclusion and 3 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 19 Sep 2025. 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 Brazil. 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 and intestinal transit time (time frame: After the 3rd day of the protocol). 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 19 Sep 2025.