The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

NCT ID: NCT01677273

Last Updated: 2013-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Increased Energy Expenditure Increased Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hydrolyzed casein

Hydrolyzed casein

Group Type ACTIVE_COMPARATOR

Hydrolyzed casein

Intervention Type DIETARY_SUPPLEMENT

30 g protein/supplement, 4 supplements/visit

Intact casein

Intact casein

Group Type ACTIVE_COMPARATOR

Intact casein

Intervention Type DIETARY_SUPPLEMENT

30 g protein/supplement, 4 supplements/visit

Intact whey protein

Intact whey protein

Group Type ACTIVE_COMPARATOR

Intact whey protein

Intervention Type DIETARY_SUPPLEMENT

30 g protein/supplement, 4 supplements/visit

Interventions

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Hydrolyzed casein

30 g protein/supplement, 4 supplements/visit

Intervention Type DIETARY_SUPPLEMENT

Intact casein

30 g protein/supplement, 4 supplements/visit

Intervention Type DIETARY_SUPPLEMENT

Intact whey protein

30 g protein/supplement, 4 supplements/visit

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Hyvital casein CMA 500, Friesland Campina Miprodan 30, Arla Foods Lacprodan SP-9225 Instant, Arla Foods

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role collaborator

Arla Foods

INDUSTRY

Sponsor Role collaborator

The Danish Dairy Research Foundation, Denmark

OTHER

Sponsor Role collaborator

FrieslandCampina

INDUSTRY

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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AAstrup

Prof., MD, Head of Department, Department of Human Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arne Astrup, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, Faculty of Science, University of Copenhagen

Locations

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Department of Human Nutrion

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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B299

Identifier Type: -

Identifier Source: org_study_id

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