Healthy Male SubjectsProVeNCT01257295
Properties of Dietary Fibre and Energy Intake
A study testing breakfast with low viscous, low gelling pectin, high viscous, low gelling pectin and low viscous, high gelling pectin in people with Healthy Male Subjects, run by Wageningen University at 1 site in Netherlands.
Trial summary
Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- breakfast with low viscous, low gelling pectin, high viscous, low gelling pectin and low viscous, high gelling pectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to May 2011
- 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
- Men only
- 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
Who cannot join
- Females
- 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: >2.89, measured by DEBQ (35).
- Smoking
Show all 17Show fewer
- Heavy alcohol use: >5 drinks/day (36).
- Reported stomach or bowel disease
- Reported diabetes
- Reported thyroid disease or any other endocrine disorder
- Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods
- Anemia: Hb<8.0 mmol/l
- Fasting glucose levels >5.8 mmol/l
- Blood donation from 6 weeks prior to the study until the end of the study
- Experienced any problems with drawing blood in the past
- Antecubital veins not considered suitable for blood drawing by means of a catheter
- Thesis students or employees of the division of Human Nutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Properties of Dietary Fibre and Energy Intake: an Intervention to Study the Effect of Physicochemical Properties of Dietary Fibre on Energy Intake and Underlying Mechanisms
Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.
- Conditions
- Healthy Male Subjects
- Being tested
- control: no fiber addition, breakfast with low viscous, low gelling pectin, high viscous, low gelling pectin, low viscous, high gelling pectin, high viscous, high gelling pectin
- Keywords
- dietary fiber, energy intake, appetite, satiety hormones, glucose, gastric emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control: no fiber additionDietary supplement
liquid breakfast without addition of fiber
breakfast with low viscous, low gelling pectinDietary supplement
10g of low viscous, low gelling pectin dissolved in a liquid breakfast
high viscous, low gelling pectinDietary supplement
10g of high viscous, low gelling pectin dissolved in a liquid breakfast
low viscous, high gelling pectinDietary supplement
10g of low viscous, high gelling pectin dissolved in a liquid breakfast
high viscous, high gelling pectinDietary supplement
10g of high viscous, high gelling pectin dissolved in a liquid breakfast
pectin supplementDietary supplement
10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | No additions of fiber to a breakfast meal Receives: Dietary Supplement: control: no fiber addition |
| low viscous, low gelling | Active comparator | low viscous, low gelling fibre added to breakfast meal Receives: Dietary Supplement: breakfast with low viscous, low gelling pectin |
| high viscous, low gelling | Active comparator | high viscous, low gelling fibre added to breakfast meal Receives: Dietary Supplement: high viscous, low gelling pectin |
| low viscous, high gelling | Active comparator | low viscous, high gelling fibre added to breakfast meal Receives: Dietary Supplement: low viscous, high gelling pectin |
| high viscous, high gelling | Active comparator | high viscous, high gelling fibre added to breakfast meal Receives: Dietary Supplement: high viscous, high gelling pectin |
| fibre supplement | Active comparator | high viscous, high gelling fibre is added, not to the breakfast meal, but as supplement Receives: Dietary Supplement: pectin supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy intake
3 hours after ingesting the test breakfast ad libitum energy intake is measured.
Measured: 3 hours
Secondary outcomes (4)
appetite sensations
appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast
Measured: 3 hours
satiety hormones
satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast
Measured: 3 hours
gastric emptying rate
gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast
Measured: 3 hours
method of supplementation
One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edith Feskens, PHd, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257295
- Sponsor's protocol ID
- METC-10/22
- Acronym
- ProVe
- Status last verified
- Dec 2011
- First submitted
- 8 Dec 2010
- Last updated
- 26 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Properties of Dietary Fibre and Energy Intake: an Intervention to Study the Effect of Physicochemical Properties of Dietary Fibre on Energy Intake and Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT01257295
- Acronym / sponsor ID
- ProVe / METC-10/22
- Conditions
- Healthy Male Subjects
- Keywords
- dietary fiber, energy intake, appetite, satiety hormones, glucose, gastric emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Dec 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 fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.
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: control: no fiber additionNo additions of fiber to a breakfast meal |
| low viscous, low gelling | Active comparator | Dietary Supplement: breakfast with low viscous, low gelling pectinlow viscous, low gelling fibre added to breakfast meal |
| high viscous, low gelling | Active comparator | Dietary Supplement: high viscous, low gelling pectinhigh viscous, low gelling fibre added to breakfast meal |
| low viscous, high gelling | Active comparator | Dietary Supplement: low viscous, high gelling pectinlow viscous, high gelling fibre added to breakfast meal |
| high viscous, high gelling | Active comparator | Dietary Supplement: high viscous, high gelling pectinhigh viscous, high gelling fibre added to breakfast meal |
| fibre supplement | Active comparator | Dietary Supplement: pectin supplementhigh viscous, high gelling fibre is added, not to the breakfast meal, but as supplement |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-30 year
- BMI 18.5-25 kg/m2
- Healthy as judged by the participant
Key exclusion criteria (17 listed)
- Females
- 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: >2.89, measured by DEBQ (35).
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 |
|---|---|---|
| control: no fiber additionliquid breakfast without addition of fiber | Dietary supplement | control |
| breakfast with low viscous, low gelling pectin10g of low viscous, low gelling pectin dissolved in a liquid breakfast | Dietary supplement | low viscous, low gelling |
| high viscous, low gelling pectin10g of high viscous, low gelling pectin dissolved in a liquid breakfast | Dietary supplement | high viscous, low gelling |
| low viscous, high gelling pectin10g of low viscous, high gelling pectin dissolved in a liquid breakfast | Dietary supplement | low viscous, high gelling |
| high viscous, high gelling pectin10g of high viscous, high gelling pectin dissolved in a liquid breakfast | Dietary supplement | high viscous, high gelling |
| pectin supplement10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately | Dietary supplement | fibre supplement |
Primary outcome
energy intake
Time frame: 3 hours
3 hours after ingesting the test breakfast ad libitum energy intake is measured.
4 secondary outcomes
appetite sensations
Time frame: 3 hours
satiety hormones
Time frame: 3 hours
gastric emptying rate
Time frame: 3 hours
method of supplementation
Time frame: 3 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 26 Dec 2011.
Related trials for Healthy Male Subjects
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Not yet recruitingPhase 1
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Health Adult Subjects
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, PHd 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 breakfast with low viscous, low gelling pectin, high viscous, low gelling pectin and low viscous, high gelling pectin in people with Healthy Male Subjects, 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 17 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 26 Dec 2011. 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: 3 hours). 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 26 Dec 2011.