- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257295
Properties of Dietary Fibre and Energy Intake (ProVe)
December 23, 2011 updated by: Wageningen University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Dietary supplement: control: no fiber addition
- Dietary supplement: breakfast with low viscous, low gelling pectin
- Dietary supplement: high viscous, low gelling pectin
- Dietary supplement: low viscous, high gelling pectin
- Dietary supplement: high viscous, high gelling pectin
- Dietary supplement: pectin supplement
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Wageningen, Netherlands, 6702
- Wageningen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age 18-30 year
- BMI 18.5-25 kg/m2
- Healthy as judged by the participant
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control
No additions of fiber to a breakfast meal
|
liquid breakfast without addition of fiber
|
Active Comparator: low viscous, low gelling
low viscous, low gelling fibre added to breakfast meal
|
10g of low viscous, low gelling pectin dissolved in a liquid breakfast
|
Active Comparator: high viscous, low gelling
high viscous, low gelling fibre added to breakfast meal
|
10g of high viscous, low gelling pectin dissolved in a liquid breakfast
|
Active Comparator: low viscous, high gelling
low viscous, high gelling fibre added to breakfast meal
|
10g of low viscous, high gelling pectin dissolved in a liquid breakfast
|
Active Comparator: high viscous, high gelling
high viscous, high gelling fibre added to breakfast meal
|
10g of high viscous, high gelling pectin dissolved in a liquid breakfast
|
Active Comparator: fibre supplement
high viscous, high gelling fibre is added, not to the breakfast meal, but as supplement
|
10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
energy intake
Time Frame: 3 hours
|
3 hours after ingesting the test breakfast ad libitum energy intake is measured.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
appetite sensations
Time Frame: 3 hours
|
appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast
|
3 hours
|
satiety hormones
Time Frame: 3 hours
|
satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast
|
3 hours
|
gastric emptying rate
Time Frame: 3 hours
|
gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast
|
3 hours
|
method of supplementation
Time Frame: 3 hours
|
One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edith Feskens, PHd, Wageningen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
December 8, 2010
First Posted (Estimate)
December 9, 2010
Study Record Updates
Last Update Posted (Estimate)
December 26, 2011
Last Update Submitted That Met QC Criteria
December 23, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- METC-10/22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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