HealthyNCT00904124
The Effect of Different Types of Dietary Fiber on Satiation
A study testing cellulose, alginate, guar gum in people with Healthy, run by Wageningen University at 1 site in Netherlands.
Trial summary
It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or meal termination, can be induced by sensory properties and energy density of fiber-rich food products, but also by the chemical/physical/rheological behavior of the fibers in the stomach and/or intestine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cellulose, alginate, guar gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to May 2010
- 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
- Age: 18-50 years
- BMI: 18-25 kg/m2
- Healthy: as judged by the participant
Who cannot join
- Weight loss or weight gain of more than 5 kg during the last 2 months
- Using an energy restricted diet during the last 2 months
- Lack of appetite for any (unknown) reason
- Having problems with chewing and swallowing
- Having problems with digestion
- Restrained eater
- Hypersensitivity for gluten or other ingredients of chocolate cookies
- Hypersensitivity for one of the fibers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effect of Different Types of Isolated Dietary Fiber on ad Libitum Food Intake in Healthy Human Subjects
It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or meal termination, can be induced by sensory properties and energy density of fiber-rich food products, but also by the chemical/physical/rheological behavior of the fibers in the stomach and/or intestine. It is not clear which properties are the key regulators of satiation by fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical properties, thus these might have different effects on satiation.
- Conditions
- Healthy
- Being tested
- cellulose, alginate, guar gum
- Keywords
- Dietary fiber, guar gum, alginate, cellulose, food intake, eating behaviour
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cellulose, alginate, guar gumDietary supplement
6 different food products are developed with different dosages of dietary fiber. Regular flour is replaced by dietary fiber, dosages are described in the 'arms'section.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No regular flour replaced Receives: Dietary Supplement: cellulose, alginate, guar gum |
| 5% Cellulose | Experimental | 5% regular flour is replaced by cellulose Receives: Dietary Supplement: cellulose, alginate, guar gum |
| 2.5% Alginate | Experimental | 2.5% regular flour is replaced by Alginate Receives: Dietary Supplement: cellulose, alginate, guar gum |
| 5% Alginate | Experimental | 5% regular flour is replaced by Alginate Receives: Dietary Supplement: cellulose, alginate, guar gum |
| 2.5% Guar gum | Experimental | 2.5% regular flour is replaced by Guar gum Receives: Dietary Supplement: cellulose, alginate, guar gum |
| 1.25% Guar gum | Experimental | 1.25% regular flour is replaced by Guar gum Receives: Dietary Supplement: cellulose, alginate, guar gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum intake
Measured: 1 hour and 2 hours
Secondary outcomes (1)
eating rate
Measured: 1 hour and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Investigators
- Edith Feskens, Dr, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904124
- Sponsor's protocol ID
- 0902-face
- Status last verified
- May 2010
- First submitted
- 17 May 2009
- Last updated
- 11 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wanders AJ, Jonathan MC, van den Borne JJ, Mars M, Schols HA, Feskens EJ, de Graaf C. The effects of bulking, viscous and gel-forming dietary fibres on satiation. Br J Nutr. 2013 Apr 14;109(7):1330-7. doi: 10.1017/S0007114512003145. Epub 2012 Jul 31.
PubMed 22850326
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Different Types of Isolated Dietary Fiber on ad Libitum Food Intake in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT00904124
- Acronym / sponsor ID
- 0902-face
- Conditions
- Healthy
- Keywords
- Dietary fiber, guar gum, alginate, cellulose, food intake, eating behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 May 2009 (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.
It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or meal termination, can be induced by sensory properties and energy density of fiber-rich food products, but also by the chemical/physical/rheological behavior of the fibers in the stomach and/or intestine. It is not clear which properties are the key regulators of satiation by fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical properties, thus these might have different effects on satiation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: cellulose, alginate, guar gumNo regular flour replaced |
| 5% Cellulose | Experimental | Dietary Supplement: cellulose, alginate, guar gum5% regular flour is replaced by cellulose |
| 2.5% Alginate | Experimental | Dietary Supplement: cellulose, alginate, guar gum2.5% regular flour is replaced by Alginate |
| 5% Alginate | Experimental | Dietary Supplement: cellulose, alginate, guar gum5% regular flour is replaced by Alginate |
| 2.5% Guar gum | Experimental | Dietary Supplement: cellulose, alginate, guar gum2.5% regular flour is replaced by Guar gum |
| 1.25% Guar gum | Experimental | Dietary Supplement: cellulose, alginate, guar gum1.25% regular flour is replaced by Guar gum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-50 years
- BMI: 18-25 kg/m2
- Healthy: as judged by the participant
Key exclusion criteria (8 listed)
- Weight loss or weight gain of more than 5 kg during the last 2 months
- Using an energy restricted diet during the last 2 months
- Lack of appetite for any (unknown) reason
- Having problems with chewing and swallowing
- Having problems with digestion
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 |
|---|---|---|
| cellulose, alginate, guar gum6 different food products are developed with different dosages of dietary fiber. Regular flour is replaced by dietary fiber, dosages are described in the 'arms'section. | Dietary supplement | 1.25% Guar gum, 2.5% Alginate, 2.5% Guar gum, 5% Alginate, 5% Cellulose, Control |
Primary outcome
Ad libitum intake
Time frame: 1 hour and 2 hours
1 secondary outcome
eating rate
Time frame: 1 hour and 2 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 11 May 2010.
- Derived from this study: PubMed 22850326Wanders AJ, Jonathan MC, van den Borne JJ, Mars M, Schols HA, Feskens EJ, de Graaf C. The effects of bulking, viscous and gel-forming dietary fibres on satiation. Br J Nutr. 2013 Apr 14;109(7):1330-7. doi: 10.1017/S0007114512003145. Epub 2012 Jul 31.
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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.
Edith Feskens, Dr principal investigator
Wageningen 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 cellulose, alginate, guar gum in people with Healthy, run by Wageningen University at 1 site in Netherlands.
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 3 inclusion and 8 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 11 May 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 Netherlands. 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.
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?
Ad libitum intake (time frame: 1 hour and 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904124, which also lists 1 linked publication.
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 11 May 2010.