Increased Energy ExpenditureHerKulESNCT01677273
The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite
A study testing Hydrolyzed casein, Intact casein and Intact whey protein in people with Increased Energy Expenditure and Increased Satiety, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Increased Energy Expenditure, Increased Satiety
- What is being tested?
- Hydrolyzed casein, Intact casein and Intact whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men and woman
- Overweight and obese (BMI 27-35 kg/m2)
- 18-40 years
- Women must have a regular menstrual cycle
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Increased Energy Expenditure, Increased Satiety
- Being tested
- Hydrolyzed casein, Intact casein, Intact whey protein
- Keywords
- Respiratory chambers, Energy expenditure, Appetite, Dairy proteins, Diet induced thermogenesis, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed caseinDietary supplement
Also called Hyvital casein CMA 500, Friesland Campina
30 g protein/supplement, 4 supplements/visit
Intact caseinDietary supplement
Also called Miprodan 30, Arla Foods
30 g protein/supplement, 4 supplements/visit
Intact whey proteinDietary supplement
Also called Lacprodan SP-9225 Instant, Arla Foods
30 g protein/supplement, 4 supplements/visit
| Study group | Role | What they receive |
|---|---|---|
| Hydrolyzed casein | Active comparator | Hydrolyzed casein Receives: Dietary Supplement: Hydrolyzed casein |
| Intact casein | Active comparator | Intact casein Receives: Dietary Supplement: Intact casein |
| Intact whey protein | Active comparator | Intact whey protein Receives: Dietary Supplement: Intact whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet-induced thermogenesis
Measured: 24 hours
Secondary outcomes (7)
Appetite assessed by visual analogue scales
Measured: 24 hours
Appetite assessed by ad libitum energy intake
Measured: 1 single meal
Appetite regulating hormones in plasma
Measured: 4 hours
Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations)
Measured: 24 hours
Differences in insulin, glucose and atrial natriuretic peptide
Measured: 4 hours
Ad libitum energy intake assessed by 24 hour dietary records
Measured: 24 hours
NMR-spectroscopy based metabonomics profiling of urin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Arla Foods, The Danish Dairy Research Foundation, Denmark, FrieslandCampina
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Arne Astrup, Prof., MD, Principal investigator, Department of Human Nutrition, Faculty of Science, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677273
- Sponsor's protocol ID
- B299
- Acronym
- HerKulES
- Status last verified
- Jul 2013
- First submitted
- 29 Aug 2012
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite
- ClinicalTrials.gov ID
- NCT01677273
- Acronym / sponsor ID
- HerKulES / B299
- Conditions
- Increased Energy Expenditure, Increased Satiety
- Keywords
- Respiratory chambers, Energy expenditure, Appetite, Dairy proteins, Diet induced thermogenesis, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Arla Foods, The Danish Dairy Research Foundation, Denmark, FrieslandCampina
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed casein | Active comparator | Dietary Supplement: Hydrolyzed caseinHydrolyzed casein |
| Intact casein | Active comparator | Dietary Supplement: Intact caseinIntact casein |
| Intact whey protein | Active comparator | Dietary Supplement: Intact whey proteinIntact whey protein |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy young men and woman
- Overweight and obese (BMI 27-35 kg/m2)
- 18-40 years
- Women must have a regular menstrual cycle
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed caseinAlso: Hyvital casein CMA 500, Friesland Campina30 g protein/supplement, 4 supplements/visit | Dietary supplement | Hydrolyzed casein |
| Intact caseinAlso: Miprodan 30, Arla Foods30 g protein/supplement, 4 supplements/visit | Dietary supplement | Intact casein |
| Intact whey proteinAlso: Lacprodan SP-9225 Instant, Arla Foods30 g protein/supplement, 4 supplements/visit | Dietary supplement | Intact whey protein |
Primary outcome
Diet-induced thermogenesis
Time frame: 24 hours
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
Related trials for Increased Energy Expenditure
Recruiting
Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
NAFLD
Active, not recruiting
Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Brown Adipose Tissue-mediated Effect Against Metabolic Syndrome (BEACON BEAMS Study)
Energy Expenditure, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Prof., MD principal investigator
Department of Human Nutrition, Faculty of Science, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed casein, Intact casein and Intact whey protein in people with Increased Energy Expenditure and Increased Satiety, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet-induced thermogenesis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.