ObesityNCT01588600
Effects of Fiber on Satiety
A study testing Dietary Fiber in people with Obesity, run by Ingredion Incorporated at 1 site in United Kingdom.
Trial summary
The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary Fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Dec 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal-weight adults
Who cannot join
- eating disorders,
- on medications that affect food intake,
- pregnant or lactating,
- non-breakfast eaters
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kissileff Laboratory for the Study of Human Ingestive Behavior
Liverpool, L69 7ZA
About this study
Official title: Effects of Fiber on Satiety and Food Intake in Men and Women
The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.
- Conditions
- Obesity
- Being tested
- Dietary Fiber
- Keywords
- food intake, satiety, fiber
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary FiberOther
Fiber added to breakfast
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Breakfast without fiber Receives: Other: Dietary Fiber |
| Low-dose | Experimental | Low-dose of fiber in breakfast Receives: Other: Dietary Fiber |
| High-dose | Experimental | high dose of fiber added to breakfast Receives: Other: Dietary Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
24-hour Food intake will be measured 3 times
Measured: 24-hr food intake, on three occasions within 3 weeks
Secondary outcomes (1)
Subjective appetite ratings
Ratings of hunger and fullness will be assessed 18 times
Measured: Hourly, over 8 hrs, on 3 days within a 3-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredion Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Halford, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588600
- Sponsor's protocol ID
- UL001
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fiber on Satiety and Food Intake in Men and Women
- ClinicalTrials.gov ID
- NCT01588600
- Acronym / sponsor ID
- UL001
- Conditions
- Obesity
- Keywords
- food intake, satiety, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ingredion IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 May 2012 (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.
The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Dietary FiberBreakfast without fiber |
| Low-dose | Experimental | Other: Dietary FiberLow-dose of fiber in breakfast |
| High-dose | Experimental | Other: Dietary Fiberhigh dose of fiber added to breakfast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- normal-weight adults
Key exclusion criteria (4 listed)
- eating disorders,
- on medications that affect food intake,
- pregnant or lactating,
- non-breakfast eaters
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 |
|---|---|---|
| Dietary FiberFiber added to breakfast | Other | Control, High-dose, Low-dose |
Primary outcome
Food intake
Time frame: 24-hr food intake, on three occasions within 3 weeks
24-hour Food intake will be measured 3 times
1 secondary outcome
Subjective appetite ratings
Time frame: Hourly, over 8 hrs, on 3 days within a 3-week period
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 21 Apr 2016.
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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.
Jason Halford, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber in people with Obesity, run by Ingredion Incorporated at 1 site in United Kingdom.
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 4 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 21 Apr 2016. 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 Kingdom. 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?
Food intake (time frame: 24-hr food intake, on three occasions within 3 weeks). 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 21 Apr 2016.