Healthy AdultsEarly Phase 1NCT01187875
Resistant Starch and Satiety
A Early Phase 1 study testing Hi-maize resistant starch 9g, Novalose 330 resistant starch 9g and 4.5g Hi-maize resistant starch and 4.5g Novalose 330 in people with Healthy Adults, run by University of Minnesota at 1 site in United States.
Trial summary
Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Hi-maize resistant starch 9g, Novalose 330 resistant starch 9g and 4.5g Hi-maize resistant starch and 4.5g Novalose 330
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2011
- Phase
- Early Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Age 18-64 years
- Non-smoking
- Not taking medication
- Non dieting (weight stable in prior 3 months)
- BMI 18-27
- English literacy
Who cannot join
- Do not regularly consume breakfast
- Food allergies to ingredients found in the study products
- BMI <18 or >27
- Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus
- Cancer in previous 5 years
- Any gastrointestinal disease or condition
Show all 15Show fewer
- Recent bacterial infection (< 3months)
- Recent or concurrent participation in an intervention research study
- History of drug or alcohol abuse in prior 6 months
- Use of lipid lowering, anti-hypertensive, or anti-inflammatory steroid medication
- Eating disorder
- Vegetarians
- People who eat more than approximately 15 grams of fiber per day
- Women who are pregnant or lactating
- Women with irregular menstrual cycles
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: Satiety Response of Resistant Starches
Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.
- Conditions
- Healthy Adults
- Being tested
- Placebo- Fiber free control, Hi-maize resistant starch 9g, Novalose 330 resistant starch 9g, 4.5g Hi-maize resistant starch and 4.5g Novalose 330
- Keywords
- satiety, dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo- Fiber free controlDietary supplement
Dextrin control administered in a muffin treatment.
Hi-maize resistant starch 9gDietary supplement
9g Hi-maize resistant starch administered in a muffin treatment.
Novalose 330 resistant starch 9gDietary supplement
9g Novalose 330 resistant starch administered in a muffin treatment.
4.5g Hi-maize resistant starch and 4.5g Novalose 330Dietary supplement
4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Dextrin Control Receives: Dietary Supplement: Placebo- Fiber free control |
| Hi-maize resistant starch 9g | Experimental | Hi-maize resistant starch 9g Receives: Dietary Supplement: Hi-maize resistant starch 9g |
| Novalose 330 resistant starch 9g | Experimental | Novalose 330 resistant starch 9g Receives: Dietary Supplement: Novalose 330 resistant starch 9g |
| 4.5g Hi-maize and 4.5g Novalose 330 | Experimental | 4.5g Hi-maize and 4.5g Novalose 330 Receives: Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety response using visual analogue scales
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 0 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 15 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 30 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 45 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 60 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 90 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 120 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 180 minutes postprandially
Satiety response using VAS
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Measured: 240 minutes postprandially
Secondary outcomes (3)
Ad libitum food intake
Measured: 240 minutes postprandially and over 24 hours
Breath hydrogen response
Measured: 0, 240 minutes
Gastrointestinal tolerance using visual analogue scales (VAS)
Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187875
- Sponsor's protocol ID
- 806M37445
- Status last verified
- Mar 2012
- First submitted
- 21 Jun 2010
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety Response of Resistant Starches
- ClinicalTrials.gov ID
- NCT01187875
- Acronym / sponsor ID
- 806M37445
- Conditions
- Healthy Adults
- Keywords
- satiety, dietary fiber
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Aug 2010 (estimated)
- 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.
Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebo- Fiber free controlDextrin Control |
| Hi-maize resistant starch 9g | Experimental | Dietary Supplement: Hi-maize resistant starch 9gHi-maize resistant starch 9g |
| Novalose 330 resistant starch 9g | Experimental | Dietary Supplement: Novalose 330 resistant starch 9gNovalose 330 resistant starch 9g |
| 4.5g Hi-maize and 4.5g Novalose 330 | Experimental | Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 3304.5g Hi-maize and 4.5g Novalose 330 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy men and women
- Age 18-64 years
- Non-smoking
- Not taking medication
- Non dieting (weight stable in prior 3 months)
Key exclusion criteria (15 listed)
- Do not regularly consume breakfast
- Food allergies to ingredients found in the study products
- BMI <18 or >27
- Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus
- Cancer in previous 5 years
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 |
|---|---|---|
| Placebo- Fiber free controlDextrin control administered in a muffin treatment. | Dietary supplement | Control |
| Hi-maize resistant starch 9g9g Hi-maize resistant starch administered in a muffin treatment. | Dietary supplement | Hi-maize resistant starch 9g |
| Novalose 330 resistant starch 9g9g Novalose 330 resistant starch administered in a muffin treatment. | Dietary supplement | Novalose 330 resistant starch 9g |
| 4.5g Hi-maize resistant starch and 4.5g Novalose 3304.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment. | Dietary supplement | 4.5g Hi-maize and 4.5g Novalose 330 |
Primary outcome
Satiety response using visual analogue scales
Time frame: 0 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 15 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 30 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 45 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 60 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 90 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 120 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 180 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Satiety response using VAS
Time frame: 240 minutes postprandially
Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
3 secondary outcomes
Ad libitum food intake
Time frame: 240 minutes postprandially and over 24 hours
Breath hydrogen response
Time frame: 0, 240 minutes
Gastrointestinal tolerance using visual analogue scales (VAS)
Time frame: 24 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 29 Mar 2012.
Related trials for Healthy Adults
RecruitingPhase 3
Weight Gain Prevention in Adolescents and Young Adults
Healthy Volunteers
Not yet recruiting
Contribution of Corticospinal and Reticulospinal Mechanisms to Neural Adaptations Induced by Muscle Strengthening of Healthy Adults
Healthy Volunteers, Resistance Training Adaptation
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Recruiting
Assessing Blood Pressure Variability in a Healthy Adult Population During Transcutaneous Hypoglossal Nerve Stimulation With the Zeus Sleep Device
Transcutaneous Hypoglossal Nerve Stimulation
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
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.
Joanne L Slavin, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hi-maize resistant starch 9g, Novalose 330 resistant starch 9g and 4.5g Hi-maize resistant starch and 4.5g Novalose 330 in people with Healthy Adults, run by University of Minnesota 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 7 inclusion and 15 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 29 Mar 2012. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Satiety response using visual analogue scales (time frame: 0 minutes postprandially). The study lists 9 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 29 Mar 2012.