Clinical trial NCT01677273: The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite
Official title: The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Energy Expenditure
Increased Satiety
Keywords: Respiratory chambers
Energy expenditure
Appetite
Dairy proteins
Diet induced thermogenesis
Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Arla Foods
name: The Danish Dairy Research Foundation, Denmark
name: FrieslandCampina
First posted: 2012-08-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore, to study the effects on appetite regulation assessed by subjective appetite sensations, ad libitum energy intake and appetite regulating hormones.

Whey and casein differ in absorption and digestion rate, with whey being a fast protein and casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion rates approaches the rates of whey. In the present study the importance of absorption rate and amino acid composition, in regards to energy expenditure and appetite regulation, will be examined. HC and IC have identical amino acid composition, but differ in absorption rate, whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption, whereas IC will be more satiating after several hours.

The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI 27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained over 24 hours and appetite will be assessed by visual analogue scales and appetite regulating hormones. Furthermore, ad libitum energy intake will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy young men and woman
* Overweight and obese (BMI 27-35 kg/m2)
* 18-40 years
* Women must have a regular menstrual cycle

Exclusion Criteria:

* Allergic to dairy products or other food components
* Vegetarians
* Weight change \>3kg within 2 months prior to start of the study
* Use of alcohol \>14 drinks/wk
* Drug abuse
* Smoking
* Physically active \>10 hrs/wk
* Use of over-the-counter or prescription medication that influences body weight, appetite or metabolism
* Diabetes Mellitus
* Dyslipidemia
* Diseases, which influence metabolism
* Donation of blood 3 months prior to start of the study
* Subjects with a hemoglobin value \< 8 mol/L (measured at screening)
* Subjects with a blood glucose level \> 6.1 mmol/l (110 mg/dl) (measured at screening)
* Subjects who are unable to give an informed consent.
* Pregnant and lactating women

Primary outcomes:
measure: Diet-induced thermogenesis
timeFrame: 24 hours
Secondary outcomes:
measure: Appetite assessed by visual analogue scales
timeFrame: 24 hours
measure: Appetite assessed by ad libitum energy intake
timeFrame: 1 single meal
measure: Appetite regulating hormones in plasma
timeFrame: 4 hours
measure: Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations)
timeFrame: 24 hours
measure: Differences in insulin, glucose and atrial natriuretic peptide
timeFrame: 4 hours
measure: Ad libitum energy intake assessed by 24 hour dietary records
timeFrame: 24 hours
measure: NMR-spectroscopy based metabonomics profiling of urin
timeFrame: 24 hours
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrion
Study officials:
affiliation: Department of Human Nutrition, Faculty of Science, University of Copenhagen
name: Arne Astrup, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: