We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677273
First Posted: August 31, 2012
Last Update Posted: July 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods
The Danish Dairy Research Foundation, Denmark
FrieslandCampina
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

Resource links provided by NLM:


Further study details as provided by AAstrup, University of Copenhagen:

Primary Outcome Measures:
  • Diet-induced thermogenesis [ Time Frame: 24 hours ]

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

Enrollment: 33
Study Start Date: September 2012
Study Completion Date: July 2013
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677273


Locations
Denmark
Department of Human Nutrion
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods
The Danish Dairy Research Foundation, Denmark
FrieslandCampina
Investigators
Principal Investigator: Arne Astrup, Prof., MD Department of Human Nutrition, Faculty of Science, University of Copenhagen
  More Information

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
First Submitted: August 29, 2012
First Posted: August 31, 2012
Last Update Posted: July 29, 2013
Last Verified: July 2013

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

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


To Top