Appetitive BehaviorNCT05349903
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
A study testing Rice flour, Alternanoligosaccharide 15 and Inulin in people with Appetitive Behavior and Obesity, run by Purdue University at 1 site in United States.
Trial summary
Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Rice flour, Alternanoligosaccharide 15 and Inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2021to 24 Feb 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 22 to 45 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)
Who cannot join
- Pregnant or nursing women
- Diabetic
- Individuals with history of gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
About this study
Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).
- Conditions
- Appetitive Behavior, Obesity, Diabetes Mellitus, Type 2
- Being tested
- Rice flour, Alternanoligosaccharide 15, Inulin, Waxy potato starch, Waxy potato starch + epigallocatechin gallate (EGCG)
- Medical subject headings
- Appetitive Behavior, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice flourOther
Rice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Alternanoligosaccharide 15Other
Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
InulinOther
Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Waxy potato starchOther
Retrograded waxy potato starch made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Waxy potato starch + epigallocatechin gallate (EGCG)Other
A combination of retrograded waxy potato starch and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Chickpea flour + epigallocatechin gallate (EGCG)Other
A combination of chickpea flour and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
| Study group | Role | What they receive |
|---|---|---|
| Rice flour | Experimental | Rapidly digestible control Receives: Other: Rice flour |
| Alternanoligosaccharide 15 | Experimental | Not described Receives: Other: Alternanoligosaccharide 15 |
| Waxy potato starch | Experimental | Not described Receives: Other: Waxy potato starch |
| Combination of waxy potato starch and epigallocatechin gallate (EGCG) | Experimental | Not described Receives: Other: Waxy potato starch + epigallocatechin gallate (EGCG) |
| Combination of chickpea flour and epigallocatechin gallate (EGCG) | Experimental | Not described Receives: Other: Chickpea flour + epigallocatechin gallate (EGCG) |
| Inulin | Experimental | Not described Receives: Other: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Blood plasma glucose will be measured, (AUC)
Measured: Acute study: [4 hours of measurement after consumption of test food]
Postprandial glycemic response
Blood plasma glucose will be measured, (C max)
Measured: Acute study: [4 hours of measurement after consumption of test food]
Postprandial glycemic response
Blood plasma glucose will be measured, (t max)
Measured: Acute study: [4 hours of measurement after consumption of test food]
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)
Measured: Acute study: [4 hours of measurement after consumption of test food]
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)
Measured: Acute study: [4 hours of measurement after consumption of test food]
Postprandial plasma gut hormone response
Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)
Measured: Acute study: [4 hours of measurement after consumption of test food]
Secondary outcomes (4)
Gastric emptying rate
Breath test will be performed using 13C-acetate mixed into test meals
Measured: Acute study: 4 hours of measurement after consumption of test food]
Appetite ratings (Visual Analog Scale, VAS)
Hunger and fullness scores will be 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]
Food Intake of the next meal
At the end of the 4 hour window, participants will be given a large second meal for consumption and the amount of consumed food (food intake) will be estimated.
Measured: Acute study: After the consumption a second meal [4 hours later after consuming the first meal]
Breath hydrogen (fermentability)
Breath samples will be 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 posted27 Apr 2022
- Study start10 Nov 2021
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- 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
- NCT05349903
- Sponsor's protocol ID
- IRB-2020-986
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2021
- Last updated
- 27 Apr 2022
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
- ClinicalTrials.gov ID
- NCT05349903
- Acronym / sponsor ID
- IRB-2020-986
- Conditions
- Appetitive Behavior, Obesity, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 27 Apr 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.
Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Rice flour | Experimental | Other: Rice flourRapidly digestible control |
| Alternanoligosaccharide 15 | Experimental | Other: Alternanoligosaccharide 15 |
| Waxy potato starch | Experimental | Other: Waxy potato starch |
| Combination of waxy potato starch and epigallocatechin gallate (EGCG) | Experimental | Other: Waxy potato starch + epigallocatechin gallate (EGCG) |
| Combination of chickpea flour and epigallocatechin gallate (EGCG) | Experimental | Other: Chickpea flour + epigallocatechin gallate (EGCG) |
| Inulin | Experimental | Other: Inulin |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5 - 25 kg/m2
- Stable weight for the past 3 months (i.e. +/- 2..5 kg)
Key exclusion criteria (3 listed)
- Pregnant or nursing women
- Diabetic
- Individuals with history of gastrointestinal disease
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 |
|---|---|---|
| Rice flourRice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability. | Other | Rice flour |
| Alternanoligosaccharide 15Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability. | Other | Alternanoligosaccharide 15 |
| InulinInulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability. | Other | Inulin |
| Waxy potato starchRetrograded waxy potato starch made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability. | Other | Waxy potato starch |
| Waxy potato starch + epigallocatechin gallate (EGCG)A combination of retrograded waxy potato starch and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability. | Other | Combination of waxy potato starch and epigallocatechin gallate (EGCG) |
| Chickpea flour + epigallocatechin gallate (EGCG)A combination of chickpea flour and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability. | Other | Combination of chickpea flour and epigallocatechin gallate (EGCG) |
Primary outcome
Postprandial glycemic response
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Blood plasma glucose will be measured, (AUC)
Postprandial glycemic response
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Blood plasma glucose will be measured, (C max)
Postprandial glycemic response
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Blood plasma glucose will be measured, (t max)
Postprandial plasma gut hormone response
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)
Postprandial plasma gut hormone response
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)
Postprandial plasma gut hormone response
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)
4 secondary outcomes
Gastric emptying rate
Time frame: Acute study: 4 hours of measurement after consumption of test food]
Appetite ratings (Visual Analog Scale, VAS)
Time frame: Acute study: [4 hours of measurement after consumption of test food]
Food Intake of the next meal
Time frame: Acute study: After the consumption a second meal [4 hours later after consuming the first meal]
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 27 Apr 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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 Rice flour, Alternanoligosaccharide 15 and Inulin in people with Appetitive Behavior and Obesity, 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 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 27 Apr 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. 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?
Postprandial glycemic response (time frame: Acute study: [4 hours of measurement after consumption of test food]). The study lists 6 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 27 Apr 2022.