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Completed

NCT Number: NCT02477410

Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrolysed porcine protein from blood

Dietary Supplement

Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Hydrolysed porcine protein from muscle

Dietary Supplement

Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Hydrolysed whey protein

Dietary Supplement

Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods
  • DC Ingredients
  • Svineafgiftsfonden

Registry information

Acronym: SEPA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2015
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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