NCT02587156

Brief Summary

12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.

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 2015

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

Study Start

First participant enrolled

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

October 22, 2015

Last Update Submit

March 2, 2018

Conditions

Protein UtilizationDietary Protein

Keywords

Required dietary proteinAmino acidSplanchnic extraction

Outcome Measures

Primary Outcomes (1)

  • Abundance of milk protein-bound amino acid labels in blood protein.

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet: After intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in liver-synthesized blood protein at 240 min.

    Baseline to 240 min postprandial

Secondary Outcomes (10)

  • Abundance of milk protein-bound amino acid labels in myofibrillar protein.

    Baseline to 240 min postprandial

  • Leg phenylalanine rate of disappearance and appearance, net balance.

    Baseline to 240 min postprandial

  • First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.

    Baseline to 240 min postprandial

  • Whole body phenylalanine rate of disappearance and appearance, net balance.

    Baseline to 240 min postprandial

  • The myofibrillar protein fractional synthesis rate

    Baseline to 240 min postprandial

  • +5 more secondary outcomes

Study Arms (2)

Meal serving at high dietary protein

EXPERIMENTAL

Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day

Dietary Supplement: Meal serving at high dietary proteinDietary Supplement: Meal serving

Meal serving at low dietary protein

ACTIVE COMPARATOR

Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day

Dietary Supplement: Meal serving at low dietary proteinDietary Supplement: Meal serving

Interventions

Meal serving at high dietary proteinDIETARY_SUPPLEMENT

Participants are habituated to a high level of dietary protein intake for 21 days.

Meal serving at high dietary protein
Meal serving at low dietary proteinDIETARY_SUPPLEMENT

Participants are habituated to a low level of dietary protein intake for 21 days.

Meal serving at low dietary protein
Meal servingDIETARY_SUPPLEMENT

To investigate impact of habituated protein level

Meal serving at high dietary proteinMeal serving at low dietary protein

Eligibility Criteria

Age65 Years - 70 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • Hyperlipidemia
  • Hypertension
  • Males age 65-70
  • Independently dwelling
  • Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
  • Non-diabetic
  • No organ disease
  • No back pain
  • Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis
  • Alcohol intake below 21 units pr. week
  • No known arthrosclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • Hojfeldt G, Bulow J, Agergaard J, Asmar A, Schjerling P, Simonsen L, Bulow J, van Hall G, Holm L. Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Dec 10;112(6):1468-1484. doi: 10.1093/ajcn/nqaa201.

    PMID: 32710741DERIVED

Study Officials

  • Grith Højfeldt, M.Sc.

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

  • Lars Holm, Ph.D.

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Human Biology - PhD student

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 27, 2015

Study Start

October 1, 2015

Primary Completion

February 8, 2018

Study Completion

February 8, 2018

Last Updated

March 5, 2018

Record last verified: 2018-03

Locations

DK(1)