HealthyEarly Phase 1NCT01100788
Satiety Response of Short Chain Fructooligosaccharide
A Early Phase 1 study testing Short chain fructo-oligosaccharide (scFOS) 5 g and Short chain fructooligosaccharide (scFOS) 8 g in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced satiety may play a key role in this relationship. The colonic fermentation of fibers is theorized to influence satiety and food intake. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Short chain fructo-oligosaccharide (scFOS) 5 g and Short chain fructooligosaccharide (scFOS) 8 g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2009
- 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 study products
- BMI <18 or >27
- Diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus
- Cancer in previous 5 years (except basal cell carcinoma of the skin)
- Any gastrointestinal disease or condition
Show all 15Show fewer
- Recent bacterial infection (< 3 months)
- 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
Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced satiety may play a key role in this relationship. The colonic fermentation of fibers is theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are rapidly fermentable fibers that can easily be added to foods to impact these parameters.
The objective of this study was to evaluate the satiety response of scFOS and its ability to decrease food intake.
Read the detailed description
Intervention study with fiber added to beverages and acute effects on satiety measured.
- Conditions
- Healthy
- Being tested
- Short chain fructo-oligosaccharide (scFOS) 5 g, Placebo, Short chain fructooligosaccharide (scFOS) 8 g
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short chain fructo-oligosaccharide (scFOS) 5 gDietary supplement
Also called fructo-oligosaccharide
Dietary Supplement: scFOS 5 g
Novel fiber administered in two 5 g doses--the first in a beverage and the second in a solid chew.
PlaceboOther
Treatment without scFOS fiber
Short chain fructooligosaccharide (scFOS) 8 gDietary supplement
Novel fiber administered in two 8 g doses--the first in a beverage and the second in a solid chew.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | No treatment Receives: Other: Placebo |
| scFOS 5 g | Experimental | 5 g scFOS Receives: Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g |
| scFOS 8 g | Experimental | 8 g scFOS Receives: Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g |
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, 15, 30, 45, 60, 90, 120, 180, 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 posted9 Apr 2010 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Joanne Slavin, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100788
- Sponsor's protocol ID
- 0806M37444
- Status last verified
- Apr 2010
- First submitted
- 5 Mar 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiety Response of Short Chain Fructooligosaccharide
- ClinicalTrials.gov ID
- NCT01100788
- Acronym / sponsor ID
- 0806M37444
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Apr 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.
Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced satiety may play a key role in this relationship. The colonic fermentation of fibers is theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are rapidly fermentable fibers that can easily be added to foods to impact these parameters.
The objective of this study was to evaluate the satiety response of scFOS and its ability to decrease food intake.
Detailed description
Intervention study with fiber added to beverages and acute effects on satiety measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboNo treatment |
| scFOS 5 g | Experimental | Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g5 g scFOS |
| scFOS 8 g | Experimental | Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g8 g scFOS |
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 study products
- BMI <18 or >27
- Diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus
- Cancer in previous 5 years (except basal cell carcinoma of the skin)
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 |
|---|---|---|
| Short chain fructo-oligosaccharide (scFOS) 5 gAlso: fructo-oligosaccharideDietary Supplement: scFOS 5 g Novel fiber administered in two 5 g doses--the first in a beverage and the second in a solid chew. | Dietary supplement | scFOS 5 g |
| PlaceboTreatment without scFOS fiber | Other | Placebo |
| Short chain fructooligosaccharide (scFOS) 8 gNovel fiber administered in two 8 g doses--the first in a beverage and the second in a solid chew. | Dietary supplement | scFOS 8 g |
Primary outcome
Satiety response using visual analogue scales
Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 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 9 Apr 2010.
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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.
Joanne Slavin 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 Short chain fructo-oligosaccharide (scFOS) 5 g and Short chain fructooligosaccharide (scFOS) 8 g in people with Healthy, 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 9 Apr 2010. 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, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially). 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 9 Apr 2010.