Appetitive BehaviorNCT04596969
The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite
A study testing Soluble Fiber Dextrin in people with Appetitive Behavior, run by Iowa State University.
Trial summary
This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Soluble Fiber Dextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 19.9 - 29.9 Aged 18-45 Find the study foods to be palatable
Who cannot join
- Weight change > 3kg in the past three months Do not regularly consume snacks Presence or history of GI disorders Restrained eater Used medication that influences appetite
About this study
Official title: The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite: a Randomized Trial
This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this study. Participants were given two doses of SFD in the morning and appetite, food intake and physiological markers of appetite were measured over 10 years.
Read the detailed description
Overweight and obesity are leading health problems. The study investigates the effect of a food ingredient from two different sources at two different doses on food intake and appetite markers over a 10 hour period. All participants reported to the laboratory first thing in the morning and remained in the laboratory until after their evening meal. A fixed breakfast was served but the participants were free to eat as much as they liked at lunch and dinner. Blood was taken at regular intervals during the day and assayed for glucose and several hormones related to appetite. Subjective measures of appetite were also collected over the 10 hour test session.
- Conditions
- Appetitive Behavior
- Being tested
- Soluble Fiber Dextrin
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Fiber DextrinOther
Ingredient based on resistant starch
| Study group | Role | What they receive |
|---|---|---|
| SFD Tapioca 20g | Experimental | 20g soluble fiber dextrin derived from tapioca Receives: Other: Soluble Fiber Dextrin |
| SFD Tapioca 40g | Experimental | 40g soluble fiber dextrin derived from tapioca Receives: Other: Soluble Fiber Dextrin |
| SFD corn 20g | Experimental | 40g soluble fiber dextrin derived from corn Receives: Other: Soluble Fiber Dextrin |
| SFD corn 40g | Experimental | Not described Receives: Other: Soluble Fiber Dextrin |
| Control | Placebo comparator | Maltodextrin Receives: Other: Soluble Fiber Dextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Food intake measured at lunch and evening meal.
Measured: 10 hours
Secondary outcomes (5)
Appetite
Subjective appetite measures using questionnaires at regular intervals over 10 hours,
Measured: 10 hours
CCK
Plasma CCK measured at regular intervals over 10 hours.
Measured: 10 hours
GLP-1
Plasma GLP-1 measured at regular intervals over 10 hours.
Measured: 10 hours
PYY3-36
Plasma PYY3-36 measured at regular intervals over 10 hours.
Measured: 10 hours
Breath Hydrogen
Breath hydrogen measured at regular intervals over 10 hours.
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2018
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
- Model description
- Human subjects
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596969
- Sponsor's protocol ID
- SFDISU
- Status last verified
- Sep 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04596969
- Acronym / sponsor ID
- SFDISU
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 22 Oct 2020 (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.
This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this study. Participants were given two doses of SFD in the morning and appetite, food intake and physiological markers of appetite were measured over 10 years.
Detailed description
Overweight and obesity are leading health problems. The study investigates the effect of a food ingredient from two different sources at two different doses on food intake and appetite markers over a 10 hour period. All participants reported to the laboratory first thing in the morning and remained in the laboratory until after their evening meal. A fixed breakfast was served but the participants were free to eat as much as they liked at lunch and dinner. Blood was taken at regular intervals during the day and assayed for glucose and several hormones related to appetite. Subjective measures of appetite were also collected over the 10 hour test session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Human subjects
| Arm | Type | Receives |
|---|---|---|
| SFD Tapioca 20g | Experimental | Other: Soluble Fiber Dextrin20g soluble fiber dextrin derived from tapioca |
| SFD Tapioca 40g | Experimental | Other: Soluble Fiber Dextrin40g soluble fiber dextrin derived from tapioca |
| SFD corn 20g | Experimental | Other: Soluble Fiber Dextrin40g soluble fiber dextrin derived from corn |
| SFD corn 40g | Experimental | Other: Soluble Fiber Dextrin |
| Control | Placebo comparator | Other: Soluble Fiber DextrinMaltodextrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 19.9 - 29.9 Aged 18-45 Find the study foods to be palatable
Key exclusion criteria (1 listed)
- Weight change > 3kg in the past three months Do not regularly consume snacks Presence or history of GI disorders Restrained eater Used medication that influences appetite
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 Fiber DextrinIngredient based on resistant starch | Other | Control, SFD Tapioca 20g, SFD Tapioca 40g, SFD corn 20g, SFD corn 40g |
Primary outcome
Food intake
Time frame: 10 hours
Food intake measured at lunch and evening meal.
5 secondary outcomes
Appetite
Time frame: 10 hours
CCK
Time frame: 10 hours
GLP-1
Time frame: 10 hours
PYY3-36
Time frame: 10 hours
Breath Hydrogen
Time frame: 10 hours
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 22 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble Fiber Dextrin in people with Appetitive Behavior, run by Iowa State University.
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 1 inclusion and 1 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Food intake (time frame: 10 hours). 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 22 Oct 2020.