The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite (HerKulES)

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.

Study Overview

• Status: Completed
• Conditions: Increased Energy Expenditure; Increased Satiety
• Intervention / Treatment: Dietary supplement: Hydrolyzed casein; Dietary supplement: Intact casein; Dietary supplement: Intact whey protein

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • Department of Human Nutrion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diet-induced thermogenesis	24 hours

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: The Danish Dairy Research Foundation, Denmark; The Ministry of Science, Technology and Innovation, Denmark; FrieslandCampina; Arla Foods
• Investigators: Principal Investigator: Arne Astrup, Prof., MD, Department of Human Nutrition, Faculty of Science, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Estimate): July 29, 2013
• Last Update Submitted That Met QC Criteria: July 26, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Energy expenditure; Obesity; Appetite; Respiratory chambers; Dairy proteins; Diet induced thermogenesis
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: B299