Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite

Hunger Clinical Trial

— SEPA  

Official title:

Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477410
• Other study ID #: H-15003581
• Status: Completed
• Phase: N/A
• First received: June 11, 2015
• Last updated: January 10, 2017
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hunger
• Protein Synthesis
• Satiety Response

Intervention

Dietary Supplement:
• Hydrolysed porcine protein from blood
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
• Hydrolysed porcine protein from muscle
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
• Hydrolysed whey protein
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Frederiksberg

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Food Ingredients Group P/S, DC Ingredients, Svineafgiftsfonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urate in urine and blood	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	No
Other	Muscle protein breakdown, gene expression	Explorative parameter	3 biopsies are taken at time 0, 150 min and 310 min. at each of the three test days	No
Other	Metabolomics - urine and blood	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	No
Primary	Change in Muscle protein synthesis (%FSR)		3 biopsies are taken at time 0, 150 min and 310 min at each visit	No
Primary	Change in Muscle protein synthesis (%FSR)		13 blood samples are taken over 310 min	No
Secondary	Visual analogue scales (10 cm)	Subjective appetite	Assessed at time 0, 160, 175, 200, 220, 250, 280, 310, 345 min at each of the three test days	No
Secondary	Appetite - ad libitum energy intake	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	No
Secondary	Postprandial response in glycemic control, plasma amino acids and appetite regulating hormones		Blood samples are taken at 0, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days	No