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Completed

NCT Number: NCT01677273

The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrion

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrolyzed casein

Dietary Supplement

30 g protein/supplement, 4 supplements/visit

Other names: Hyvital casein CMA 500, Friesland Campina

Intact casein

Dietary Supplement

30 g protein/supplement, 4 supplements/visit

Other names: Miprodan 30, Arla Foods

Intact whey protein

Dietary Supplement

30 g protein/supplement, 4 supplements/visit

Other names: Lacprodan SP-9225 Instant, Arla Foods

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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods
  • FrieslandCampina
  • The Danish Dairy Research Foundation, Denmark
  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Acronym: HerKulES

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2012
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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