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

January 10, 2017 updated by: Arne Astrup, University of Copenhagen

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.

Study Overview

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

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frederiksberg, Denmark, 1958
        • Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrolysed porcine protein from blood
Dietary intervention with 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
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
Experimental: Hydrolysed whey protein
Dietary intervention with hydrolysed whey protein
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Muscle protein synthesis (%FSR)
Time Frame: 3 biopsies are taken at time 0, 150 min and 310 min at each visit
3 biopsies are taken at time 0, 150 min and 310 min at each visit
Change in Muscle protein synthesis (%FSR)
Time Frame: 13 blood samples are taken over 310 min
13 blood samples are taken over 310 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed at time 0, 160, 175, 200, 220, 250, 280, 310, 345 min at each of the three test days
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
Measured once at time 325 min at each of the three test days
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
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

Outcome Measure
Measure Description
Time Frame
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
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
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 biopsies are taken at time 0, 150 min and 310 min. at each of the three test days
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arne Astrup, DMSc, Department of Nutrition, Exercise and Sports, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • H-15003581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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