- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133964
Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure (MAES)
Study Overview
Detailed Description
Several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. The effect seems to be due to a higher diet induced thermogenesis and increase satiety.
Milk has a high content of proteins. It contains two very different types of protein: whey and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. It is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently.
The aim of the present study is to examine the effect of dairy proteins (whey and casein) on postprandial energy expenditure, substrate oxidation and appetite regulation.
The study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 1958
- Department og Human Nutrition, Life, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy males
- body mass index (BMI) 25-30 kg/m2
- 18-50 years
- weight stable
Exclusion Criteria:
- smoker
- regular use of medicine
- elitist athletes
- participation in other intervention studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: milk
skim milk
|
Protein drinks with 3.5% protein.
The protein source will be whey, casein or whey and casein (20:80; normal content in the milk).
In the arm with water no protein will be added.
|
Experimental: casein drink
|
Protein drinks with 3.5% protein.
The protein source will be whey, casein or whey and casein (20:80; normal content in the milk).
In the arm with water no protein will be added.
|
Experimental: whey drink
|
Protein drinks with 3.5% protein.
The protein source will be whey, casein or whey and casein (20:80; normal content in the milk).
In the arm with water no protein will be added.
|
Sham Comparator: water
|
Protein drinks with 3.5% protein.
The protein source will be whey, casein or whey and casein (20:80; normal content in the milk).
In the arm with water no protein will be added.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective appetite sensation
Time Frame: 5 hours
|
5 hours
|
Energy expenditure
Time Frame: 5 hours
|
5 hours
|
Substrate oxidation
Time Frame: 5 hours
|
5 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arne Astrup, Dr., Department of Human Nutrition, Life, University of Copenhagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B256
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
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
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
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | 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
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on dairy proteins
-
LactalisCompleted
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
University of GuelphUniversity of Saskatchewan; Purdue UniversityWithdrawn
-
University of TennesseeCompleted
-
University of KansasDairy Management Inc.CompletedChildhood ObesityUnited States
-
Fred Hutchinson Cancer CenterUniversity of WashingtonCompletedInflammation | Obesity | Diabetes | Metabolic Syndrome | Insulin Resistance | NAFLDUnited States
-
USDA, Western Human Nutrition Research CenterIowa State UniversityCompleted
-
Laval UniversityDairy Farmers of CanadaCompletedCardiovascular DiseaseCanada
-
Danone ResearchCompletedHealthyBelgium, France, Spain, United Kingdom
-
University of ConnecticutDairy Management Inc.RecruitingObesity | DyslipidemiasUnited States