NCT03301337

Brief Summary

The purpose of the project is to provide evidence for the use of hydrolysed meat protein (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily protein intake. The study will investigate how the meat protein derived amino acids (from either HMP, steak or minced meat) are absorbed and released into the blood circulation of elderly persons. Hereby, the study will explore the the anabolic potential of HMP compared with common meat products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

September 28, 2017

Last Update Submit

November 18, 2022

Conditions

Amino Acid Metabolism

Keywords

Amino acid uptakeAgingMeat protein

Outcome Measures

Primary Outcomes (1)

  • D5-phenylalanine appearance

    D5-phenylalanine appearance in the blood circulation after meal consumption

    5 hours

Secondary Outcomes (1)

  • Insulin concentration

    5 hours

Study Arms (3)

Hydrolyzed meat protein

EXPERIMENTAL

D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.

Dietary Supplement: Meat protein absorption

Minced Meat

EXPERIMENTAL

D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.

Dietary Supplement: Meat protein absorption

Beef

EXPERIMENTAL

D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.

Dietary Supplement: Meat protein absorption

Interventions

Meat protein absorptionDIETARY_SUPPLEMENT

Meat protein absorption when digested together with a full meal.

BeefHydrolyzed meat proteinMinced Meat

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy
  • Untrained

You may not qualify if:

  • below 65 years of age
  • BMI above 30
  • Smokers
  • Vegetarians
  • Subjects with diabetes or other metabolic diseases
  • Medical treatment affecting protein synthesis
  • Gastro-intestinal problems, reduced liver or kidney function, elevated blood pressure, atherosclerosis
  • More than 5 ours regular physical activity per week (except physical activity related to commuting)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, DK-2400, Denmark

Location

Study Officials

  • Jakob Agergaard, PhD

    Institute of Sports Medicine, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assessor and investigator will be blindet. Participants cannot be blindet, as they will consume three different meat products, that we cannot mask.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Single-blindet randomized cross-over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc, PhD

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 4, 2017

Study Start

October 4, 2017

Primary Completion

January 30, 2018

Study Completion

October 30, 2019

Last Updated

November 21, 2022

Record last verified: 2022-11

Locations

DK(1)