NCT02477410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

June 11, 2015

Last Update Submit

January 10, 2017

Conditions

HungerSatiety ResponseProtein Synthesis

Keywords

porcine proteinappetitemuscle protein synthesisgastrointestinal hormones

Outcome Measures

Primary Outcomes (2)

  • Change in Muscle protein synthesis (%FSR)

    3 biopsies are taken at time 0, 150 min and 310 min at each visit

  • Change in Muscle protein synthesis (%FSR)

    13 blood samples are taken over 310 min

Secondary Outcomes (3)

  • Visual analogue scales (10 cm)

    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

    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

    Blood samples are taken at 0, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days

Other Outcomes (3)

  • Urate in urine and blood

    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

    3 biopsies are taken at time 0, 150 min and 310 min. at each of the three test days

  • Metabolomics - urine and blood

    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

Study Arms (3)

Hydrolysed porcine protein from blood

EXPERIMENTAL

Dietary intervention with hydrolysed porcine protein from blood

Dietary Supplement: Hydrolysed porcine protein from blood

Hydrolysed porcine protein from muscle

EXPERIMENTAL

Dietary intervention with hydrolysed porcine protein from muscle

Dietary Supplement: Hydrolysed porcine protein from muscle

Hydrolysed whey protein

EXPERIMENTAL

Dietary intervention with hydrolysed whey protein

Dietary Supplement: Hydrolysed whey protein

Interventions

Hydrolysed porcine protein from bloodDIETARY_SUPPLEMENT

Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Hydrolysed porcine protein from blood
Hydrolysed porcine protein from muscleDIETARY_SUPPLEMENT

Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Hydrolysed porcine protein from muscle
Hydrolysed whey proteinDIETARY_SUPPLEMENT

Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite

Hydrolysed whey protein

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Frederiksberg, 1958, Denmark

Location

Study Officials

  • Arne Astrup, DMSc

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., DM. DMSc.

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 22, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 11, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)