HealthyFLiTSNCT01526759
Fiber Longer Term Study on Energy Intake
A study testing LM pectin (10%) and gelatin in people with Healthy, run by Wageningen University at 1 site in Netherlands.
Trial summary
Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LM pectin (10%) and gelatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2011to Mar 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-30 year
- BMI: 18.5-25 kg/m2
- Healthy: as judged by the participant
- H2 producer
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 reason
- Restrained eater
- Smoking
- Heavy alcohol use: >5 drinks/day
Show all 18Show fewer
- Reported stomach or bowel diseases or disorders (e.g. irritable bowel syndrome)
- Reported diabetes
- Reported thyroid disease or any other endocrine disorder
- Using medication other than birth control, paracetamol, aspirin, hey fever and asthma
- Antibiotic use <2 months before the study
- Reported intolerance, allergy, or not liking of the research foods
- Vegetarian
- Current dietary fibre supplementation
- Fasting glucose levels >5.8 mmol/l
- Experienced any problems with drawing blood in the past
- Thesis students or employees of the division of Human Nutrition
- Volunteers who participated in the ProVe study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake
Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.
The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.
- Conditions
- Healthy
- Being tested
- LM pectin (10%), gelatin
- Keywords
- dietary fiber, energy intake, satiety, physicochemical properties, men and women, Healthy adults
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM pectin (10%)Dietary supplement
15 days 1 daily consumption of a drink with 10g pectin added
gelatinDietary supplement
15 days 1 daily consumption of a drink with 10g gelatin added
| Study group | Role | What they receive |
|---|---|---|
| pectin | Experimental | 10 gram high gelling-high viscous fiber, added to a drink Receives: Dietary Supplement: LM pectin (10%) |
| control | Placebo comparator | 10g gelatin, added to a drink Receives: Dietary Supplement: gelatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
after 14 days of both intervention and placebo supplements ad libitum energy intake is measured for 3 days in a row. The change in energy intake will be calculated.
Measured: change from placebo after 2 weeks
Secondary outcomes (8)
satiety
at day 1 and after 15 days of both supplement and placebo intake satiety is measured hourly over 1 day at waking hours. The change in satiety will be calculated.
Measured: change from placebo after 1 day and 15 days
fasting glucose
at day 0, 1 and day 15 of supplementation period fasting glucose is measured
Measured: change from placebo after day 0, 1 and 15
fasting insulin
at day 0, 1 and day 15 of supplementation period fasting insulin is measured
Measured: change from placebo after day 0, 1 and 15
fasting leptin
at day 0, 1 and day 15 of supplementation period fasting leptin is measured
Measured: change from placebo after day 0, 1 and 15
hydrogen in breath
at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours
Measured: change from placebo after day 2 and 15
energy intake
before supplement intake and after 1 day of supplement 1-day ad libitum energy intake is measured. The change in energy intake will be calculated.
Measured: change from placebo after day 0 and 1
body weight
Each day the subject reports to the research center, body weight is measured. The change in body weight compared to placebo will be calculated.
Measured: change from placebo after day 0,1,2,14,15, 16 and 17
adverse events
participants will be asked to register adverse events daily in a diary. They are also asked to report ae's to the researchers. number and type of AEs after fibre supplements will be compared to number and type of AEs after placebo supplements
Measured: daily from day 0 to day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edith Feskens, Prof, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526759
- Sponsor's protocol ID
- NL38515.081.11
- Acronym
- FLiTS
- Status last verified
- Mar 2012
- First submitted
- 23 Dec 2011
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake
- ClinicalTrials.gov ID
- NCT01526759
- Acronym / sponsor ID
- FLiTS / NL38515.081.11
- Conditions
- Healthy
- Keywords
- dietary fiber, energy intake, satiety, physicochemical properties, men and women, Healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Feb 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.
Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.
The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pectin | Experimental | Dietary Supplement: LM pectin (10%)10 gram high gelling-high viscous fiber, added to a drink |
| control | Placebo comparator | Dietary Supplement: gelatin10g gelatin, added to a drink |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-30 year
- BMI: 18.5-25 kg/m2
- Healthy: as judged by the participant
- H2 producer
Key exclusion criteria (18 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 reason
- Restrained eater
- Smoking
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 |
|---|---|---|
| LM pectin (10%)15 days 1 daily consumption of a drink with 10g pectin added | Dietary supplement | pectin |
| gelatin15 days 1 daily consumption of a drink with 10g gelatin added | Dietary supplement | control |
Primary outcome
Energy intake
Time frame: change from placebo after 2 weeks
after 14 days of both intervention and placebo supplements ad libitum energy intake is measured for 3 days in a row. The change in energy intake will be calculated.
8 secondary outcomes
satiety
Time frame: change from placebo after 1 day and 15 days
fasting glucose
Time frame: change from placebo after day 0, 1 and 15
fasting insulin
Time frame: change from placebo after day 0, 1 and 15
fasting leptin
Time frame: change from placebo after day 0, 1 and 15
hydrogen in breath
Time frame: change from placebo after day 2 and 15
energy intake
Time frame: change from placebo after day 0 and 1
body weight
Time frame: change from placebo after day 0,1,2,14,15, 16 and 17
adverse events
Time frame: daily from day 0 to day 16
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 12 Mar 2012.
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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, Prof 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 LM pectin (10%) and gelatin 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 4 inclusion and 18 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 12 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 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?
Energy intake (time frame: change from placebo after 2 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 12 Mar 2012.