ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite (SEPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02477410
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : January 11, 2017
Sponsor:
Collaborators:
Svineafgiftsfonden
DC Ingredients
Arla Food Ingredients Group P/S
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:

The purpose of the study is to obtain a better understanding of how hydrolysed porcine proteins affect the human metabolism, including the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones.

It is hypothesised that hydrolysed porcine proteins will stimulate muscle protein synthesis, affect appetite and the secretion of gastrointestinal hormones similar to hydrolysed whey protein.


Condition or disease Intervention/treatment Phase
Hunger Satiety Response Protein Synthesis Dietary Supplement: Hydrolysed porcine protein from blood Dietary Supplement: Hydrolysed porcine protein from muscle Dietary Supplement: Hydrolysed whey protein Not Applicable

Detailed Description:

Previous data show that proteins enhance satiety, decrease hunger and decrease energy intake. In addition, amino acids from dietary protein act as building blocks for de novo protein synthesis and consumption of dietary protein therefore stimulates protein synthesis. Proteins from different sources differ in amino acid composition and rate of absorption. Previously, studies on the effects of proteins on especially muscle protein synthesis has focused on milk proteins, whey and casein as animal sources, but other protein sources high in essential and branched-chain amino acids may also have beneficial effects on muscle protein synthesis and appetite. Thus, in this study the effects of two hydrolysed porcine proteins (one from porcine blood and one from porcine muscle) on muscle protein synthesis, appetite and secretion of gastrointestinal hormones will be compared with the effects of hydrolysed whey protein. These porcine proteins have never previously been tested and it is hypothesised that they may induce similar effects as hydrolysed whey protein due to the high contents of essential and branched-chain amino acids.

The study will be conducted as a randomised, 3-way, cross-over study. It consists of three visits separated by at least two weeks. It is expected that 18 normal-weight, young men will complete the study. They will be randomised to the order of the three proteins; hydrolysed porcine protein from blood (HPB), hydrolysed porcine protein from muscle (HPM) and hydrolysed whey protein (HW). At each visit the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones will be measured/assessed. Muscle protein synthesis will be measured after consumption of a low (15 g) and a high (30 g) dose of protein and appetite and secretion of gastrointestinal hormones will be measured after the high protein dose (30 g). The effect on muscle protein synthesis will be measured by a flood-primed continuous infusion of labelled (Ring13C6) phenylalanine, muscle biopsies and blood samples. The effects on appetite will be assessed by visual analogue scales, an ad libitum meal and blood samples.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Hydrolysed porcine protein from blood
Dietary intervention with hydrolysed porcine protein from blood
Dietary Supplement: Hydrolysed porcine protein from blood
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Experimental: Hydrolysed porcine protein from muscle
Dietary intervention with hydrolysed porcine protein from muscle
Dietary Supplement: Hydrolysed porcine protein from muscle
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Experimental: Hydrolysed whey protein
Dietary intervention with hydrolysed whey protein
Dietary Supplement: Hydrolysed whey protein
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite




Primary Outcome Measures :
  1. Change in Muscle protein synthesis (%FSR) [ Time Frame: 3 biopsies are taken at time 0, 150 min and 310 min at each visit ]
  2. Change in Muscle protein synthesis (%FSR) [ Time Frame: 13 blood samples are taken over 310 min ]

Secondary Outcome Measures :
  1. Visual analogue scales (10 cm) [ Time Frame: Assessed at time 0, 160, 175, 200, 220, 250, 280, 310, 345 min at each of the three test days ]
    Subjective appetite

  2. Appetite - ad libitum energy intake [ Time Frame: Measured once at time 325 min at each of the three test days ]
    At 325 min an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded

  3. Postprandial response in glycemic control, plasma amino acids and appetite regulating hormones [ Time Frame: Blood samples are taken at 0, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days ]

Other Outcome Measures:
  1. Urate in urine and blood [ Time Frame: Blood samples are taken at 0, 20, 40, 60, 90, 120, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days. Urine is collected over 310 min at each test day ]
    Explorative parameter

  2. Muscle protein breakdown, gene expression [ Time Frame: 3 biopsies are taken at time 0, 150 min and 310 min. at each of the three test days ]
    Explorative parameter

  3. Metabolomics - urine and blood [ Time Frame: Blood samples are taken at 0, 20, 40, 60, 90, 120, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days. Urine is collected over 310 min at each test day ]
    Explorative parameter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young men
  • Normal weight (BMI 18.5-25 kg/m2)
  • 22-40 years

Exclusion Criteria:

  • Vegetarians
  • Weight change >3kg within 2 months prior to start of the study
  • Regular participation in cardio/strength training within 6 months prior to (and during) the study (>1 per wk)
  • Use of alcohol >14 drinks/wk
  • Drug abuse
  • Smoking
  • Regular consumption of protein supplements
  • 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 (and during) the study
  • Subjects with a hemoglobin value < 8 mol/L (measured at screening)
  • Participation in other clinical studies 1 month prior to start of (and during) the study
  • Subjects who are unable to give an informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477410


Locations
Denmark
Department of Nutrition, Exercise and Sports
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Svineafgiftsfonden
DC Ingredients
Arla Food Ingredients Group P/S
Investigators
Principal Investigator: Arne Astrup, DMSc Department of Nutrition, Exercise and Sports, University of Copenhagen

Responsible Party: Arne Astrup, Prof., DM. DMSc., University of Copenhagen
ClinicalTrials.gov Identifier: NCT02477410     History of Changes
Other Study ID Numbers: H-15003581
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arne Astrup, University of Copenhagen:
porcine protein
appetite
muscle protein synthesis
gastrointestinal hormones