Increased Energy Expenditure Clinical Trial
— HerKulESOfficial title:
The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite
| Verified date | July 2013 |
| Source | University of Copenhagen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Human Nutrion | Frederiksberg |
| Lead Sponsor | Collaborator |
|---|---|
| University of Copenhagen | Arla Foods, FrieslandCampina, The Danish Dairy Research Foundation, Denmark, The Ministry of Science, Technology and Innovation, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diet-induced thermogenesis | 24 hours | No | |
| Secondary | Appetite assessed by visual analogue scales | 24 hours | No | |
| Secondary | Appetite assessed by ad libitum energy intake | 1 single meal | No | |
| Secondary | Appetite regulating hormones in plasma | 4 hours | No | |
| Secondary | Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations) | 24 hours | No | |
| Secondary | Differences in insulin, glucose and atrial natriuretic peptide | 4 hours | No | |
| Secondary | Ad libitum energy intake assessed by 24 hour dietary records | 24 hours | No | |
| Secondary | NMR-spectroscopy based metabonomics profiling of urin | 24 hours | No |