The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite

NCT01677273 | Completed

• 1 other identifier: B299
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Increased Energy Expenditure; Increased Satiety

Keywords

Respiratory chambers; Energy expenditure; Appetite; Dairy proteins; Diet induced thermogenesis; Obesity

Outcome Measures

Primary Outcomes (1)

• Diet-induced thermogenesis

  24 hours

Secondary Outcomes (7)

• Appetite assessed by visual analogue scales

  24 hours

• Appetite assessed by ad libitum energy intake

  1 single meal

• Appetite regulating hormones in plasma

  4 hours

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

  24 hours

• Differences in insulin, glucose and atrial natriuretic peptide

  4 hours

Study Arms (3)

Hydrolyzed casein

ACTIVE COMPARATOR

Hydrolyzed casein

Dietary Supplement: Hydrolyzed casein

Intact casein

ACTIVE COMPARATOR

Intact casein

Dietary Supplement: Intact casein

Intact whey protein

ACTIVE COMPARATOR

Intact whey protein

Dietary Supplement: Intact whey protein

Interventions

Hydrolyzed casein DIETARY_SUPPLEMENT

30 g protein/supplement, 4 supplements/visit

Also known as: Hyvital casein CMA 500, Friesland Campina

Hydrolyzed casein

Intact casein DIETARY_SUPPLEMENT

30 g protein/supplement, 4 supplements/visit

Also known as: Miprodan 30, Arla Foods

Intact casein

Intact whey protein DIETARY_SUPPLEMENT

30 g protein/supplement, 4 supplements/visit

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

Intact whey protein

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy young men and woman
• Overweight and obese (BMI 27-35 kg/m2)
• years
• Women must have a regular menstrual cycle

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• The Ministry of Science, Technology and Innovation, Denmark: collaborator
• Arla Foods: collaborator
• The Danish Dairy Research Foundation, Denmark: collaborator
• FrieslandCampina: collaborator

Study Sites (1)

Department of Human Nutrion

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne Astrup, Prof., MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, Head of Department, Department of Human Nutrition

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

DK (1)