CClinicalTrials.gg
CompletedNCT01677273HerKulESUpdated Jul 29, 2013

The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

An interventional study of Hydrolyzed casein and Intact casein in Increased Energy Expenditure and Increased Satiety, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-29.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Increased Energy Expenditure
  • Increased Satiety

Keywords

  • Respiratory chambers
  • Energy expenditure
  • Appetite
  • Dairy proteins
  • Diet induced thermogenesis
  • Obesity
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Active comparator
    Hydrolyzed casein

    Hydrolyzed casein

    Dietary Supplement: Hydrolyzed casein

  • Active comparator
    Intact casein

    Intact casein

    Dietary Supplement: Intact casein

  • Active comparator
    Intact whey protein

    Intact whey protein

    Dietary Supplement: Intact whey protein

Interventions

  • Dietary supplementHydrolyzed casein

    30 g protein/supplement, 4 supplements/visit

    Also known as: Hyvital casein CMA 500, Friesland Campina

  • Dietary supplementIntact casein

    30 g protein/supplement, 4 supplements/visit

    Also known as: Miprodan 30, Arla Foods

  • Dietary supplementIntact whey protein

    30 g protein/supplement, 4 supplements/visit

    Also known as: Lacprodan SP-9225 Instant, Arla Foods

06

What researchers measure

Primary outcomes

  1. Diet-induced thermogenesis

    Time frame: 24 hours

Secondary outcomes

  1. Appetite assessed by visual analogue scales

    Time frame: 24 hours

  2. Appetite assessed by ad libitum energy intake

    Time frame: 1 single meal

  3. Appetite regulating hormones in plasma

    Time frame: 4 hours

  4. Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations)

    Time frame: 24 hours

  5. Differences in insulin, glucose and atrial natriuretic peptide

    Time frame: 4 hours

  6. Ad libitum energy intake assessed by 24 hour dietary records

    Time frame: 24 hours

  7. NMR-spectroscopy based metabonomics profiling of urin

    Time frame: 24 hours

07

Study locations

1 site
  • Department of Human Nutrion
    Frederiksberg, 1958, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01677273
Lead sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, Arla Foods, The Danish Dairy Research Foundation, Denmark, FrieslandCampina
Responsible party
AAstrup (Prof., MD, Head of Department, Department of Human Nutrition, University of Copenhagen) — Principal investigator
First posted
Aug 31, 2012
Start date
Sep 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 29, 2013

Study contacts

Arne Astrup, Prof., MD
principal investigator · Department of Human Nutrition, Faculty of Science, University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion