NCT02732353

Brief Summary

To measure the absorption kinetics and postprandial amino acid availability after ingestion of minced beef compared with hydrolyzed beef in young males. Moreover, the basal muscle protein synthesis and the postprandial muscle protein synthetic response to minced beef and hydrolyzed beef ingestion are measured in young males. The postprandial muscle protein synthetic response is measured and compared during the early postprandial period (0-3 hours) after ingestion of the two meat products.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

March 30, 2016

Last Update Submit

November 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in skeletal muscle protein fractional synthetic rate

    The fractional synthetic rate of skeletal muscle proteins (%/h) measured during the overnight fasted state and the postprandial state.

    During the postprandial period (0-3 hrs).

Secondary Outcomes (2)

  • Protein absorption

    During the postprandial period (0-3 hrs).

  • Plasma amino acid concentration

    During the postprandial period (0-3 hrs).

Study Arms (2)

Minced beef

ACTIVE COMPARATOR

Minced beef

Dietary Supplement: Minced beef

Hydrolyzed beef

EXPERIMENTAL

Hydrolyzed beef

Dietary Supplement: Hydrolyzed beef

Interventions

Minced beefDIETARY_SUPPLEMENT

Cow meat protein supplement

Minced beef
Hydrolyzed beefDIETARY_SUPPLEMENT

Cow meat protein supplement

Hydrolyzed beef

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-obese (BMI\<30)

You may not qualify if:

  • Chronic medical disease
  • \>5 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

Study Officials

  • Kasper Dideriksen, PhD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR
  • Lars Holm, PhD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR
  • Søren Reitelseder, PhD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasper Dideriksen, PhD

CONTACT

Lars Holm, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, Post doc

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 8, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations