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

This study is currently recruiting participants.
Verified November 2012 by University of Copenhagen
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods Ingredients Group P/S, Denmark
The Danish Dairy Research Foundation, Denmark
FrieslandCampina Domo EMEA, The Netherlands
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01677273
First received: August 29, 2012
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Increased Energy Expenditure
Increased Satiety
 Dietary Supplement: Hydrolyzed casein
Dietary Supplement: Intact casein
Dietary Supplement: Intact whey protein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

Resource links provided by NLM:

Drug Information available for: Casein
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Diet-induced thermogenesis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appetite assessed by visual analogue scales [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Appetite assessed by ad libitum energy intake [ Time Frame: 1 single meal ] [ Designated as safety issue: No ]
  • Appetite regulating hormones in plasma [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Differences in insulin, glucose and atrial natriuretic peptide [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Ad libitum energy intake assessed by 24 hour dietary records [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • NMR-spectroscopy based metabonomics profiling of urin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydrolyzed casein
Hydrolyzed casein
 Dietary Supplement: Hydrolyzed casein
30 g protein/supplement, 4 supplements/visit
Other Name: Hyvital casein CMA 500, Friesland Campina
Active Comparator: Intact casein
Intact casein
 Dietary Supplement: Intact casein
30 g protein/supplement, 4 supplements/visit
Other Name: Miprodan 30, Arla Foods
Active Comparator: Intact whey protein
Intact whey protein
 Dietary Supplement: Intact whey protein
30 g protein/supplement, 4 supplements/visit
Other Name: Lacprodan SP-9225 Instant, Arla Foods

  Eligibility

Ages Eligible for Study:   22 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young men and woman
  • Overweight and obese (BMI 27-35 kg/m2)
  • 22-40 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677273

Contacts
Contact: Line Q Bendtsen, MSc. Pharm +45 2494 2601 lbe@life.ku.dk
Contact: Janne K Lorenzen, PhD +45 3533 2619 jakh@life.ku.dk

Locations
Denmark
Department of Human Nutrion Recruiting
Frederiksberg, Denmark, 1958
Contact: Line Q Bendtsen, Msc. Pharm     +45 2494 2601     lbe@life.ku.dk    
Contact: Janne K Lorenzen, PhD     +45 3533 2619     jakh@life.ku.dk    
Principal Investigator: Arne Astrup, Prof., MD            
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods Ingredients Group P/S, Denmark
The Danish Dairy Research Foundation, Denmark
FrieslandCampina Domo EMEA, The Netherlands
Investigators
Principal Investigator: Arne Astrup, Prof., MD Department of Human Nutrition, Faculty of Science, University of Copenhagen
  More Information

No publications provided

Responsible Party: AAstrup, Prof., MD, Head of Department, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01677273     History of Changes
Other Study ID Numbers: B299
Study First Received: August 29, 2012
Last Updated: November 19, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
Respiratory chambers
Energy expenditure
Appetite
 Dairy proteins
Diet induced thermogenesis
Obesity

Additional relevant MeSH terms:
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013