- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025375
Effects of Inulin on Satiety and Food Intake (Inulin)
August 29, 2012 updated by: Maastricht University Medical Center
To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Based upon a slower digestion and the fermentation in the intestinal tract, food containing soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit energy intake, in humans.
Does supplementation of inulin (at 2 dosages) versus placebo over 13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a reduction in food intake and stronger postprandial increases in GLP-1 and PYY?
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht 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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 18 and 60 years
- BMI between 23 and 28 kg/m2
- dietary unrestraint (TFEQ: F1<9)
Exclusion Criteria:
- age under 18 and above 60 years
- BMI under 23 and above 28 kg/m2
- dietary restraint (TFEQ: F1>9)
- use of medication
- pregnant or breastfeeding
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
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
food intake
Time Frame: on testday 0 and 13
|
on testday 0 and 13
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
appetite profile ratings
Time Frame: on test day 0, 8 and 13 (at 16 time points)
|
on test day 0, 8 and 13 (at 16 time points)
|
|
satiety hormones (GLP-1 and PYY)
Time Frame: on test day 0 and 13 (at 9 time points
|
on test day 0 and 13 (at 9 time points
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Klaas R Westerterp, Prof, NUTRIM
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
January 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 2, 2009
First Posted (Estimate)
December 3, 2009
Study Record Updates
Last Update Posted (Estimate)
August 30, 2012
Last Update Submitted That Met QC Criteria
August 29, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HumBio_Westerterp08_2
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.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on inulin
-
Yale UniversityVA Connecticut Healthcare System; National Center for Complementary and Integrative...Not yet recruitingKnee OsteoarthritisUnited States
-
Maastricht University Medical CenterCompleted
-
Scottish Universities Environmental Research CentreUniversity of Glasgow; NHS Greater Clyde and GlasgowCompletedObesity | OverweightUnited Kingdom
-
Sun Yat-sen UniversityRecruiting
-
Augusta UniversityAmerican Gastroenterological Association FoundationCompletedInvestigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Dose Response StudyHealthy VolunteersUnited States
-
University of Illinois at Urbana-ChampaignRenal Research InstituteCompletedBone Diseases, Endocrine | Nutritional and Metabolic DiseasesUnited States
-
University of ExeterUniversity of East AngliaCompletedEndothelial Dysfunction | High Blood Pressure | Gut Microbiota Dysbiosis and NutritionUnited Kingdom
-
Eskisehir Osmangazi UniversityUnknownFunctional Constipation
-
University of ReadingUnknownOverweight and ObesityUnited Kingdom
-
Imperial College LondonUniversity of GlasgowCompletedAppetite Regulation | Healthy Obesity, MetabolicallyUnited Kingdom