The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

Conditions
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Increased Energy Expenditure, Increased Satiety

Intervention / Treatment
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* Dietary Supplement: Hydrolyzed casein
* Dietary Supplement: Intact casein
* Dietary Supplement: Intact whey protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrolyzed casein<br>Hydrolyzed casein | Dietary Supplement: Hydrolyzed casein<br>* 30 g protein/supplement, 4 supplements/visit<br>* Other names: Hyvital casein CMA 500, Friesland Campina;|
| Active Comparator: Intact casein<br>Intact casein | Dietary Supplement: Intact casein<br>* 30 g protein/supplement, 4 supplements/visit<br>* Other names: Miprodan 30, Arla Foods;|
| Active Comparator: Intact whey protein<br>Intact whey protein | Dietary Supplement: Intact whey protein<br>* 30 g protein/supplement, 4 supplements/visit<br>* Other names: Lacprodan SP-9225 Instant, Arla Foods;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet-induced thermogenesis |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite assessed by visual analogue scales |  | 24 hours | 
| Appetite assessed by ad libitum energy intake |  | 1 single meal | 
| Appetite regulating hormones in plasma |  | 4 hours | 
| Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations) |  | 24 hours | 
| Differences in insulin, glucose and atrial natriuretic peptide |  | 4 hours | 
| Ad libitum energy intake assessed by 24 hour dietary records |  | 24 hours | 
| NMR-spectroscopy based metabonomics profiling of urin |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy expenditure, Appetite, Dairy proteins, Respiratory chambers, Diet induced thermogenesis, Obesity