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Completed

NCT Number: NCT02587156

Fate of Nutrient-Derived Amino Acids, FONDAA

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.

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Key information

Conditions

Protein Utilization Dietary Protein

Age range

65 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • Hyperlipidemia
  • Hypertension

Inclusion criteria

  • 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

Treatment and study plan

Meal serving at high dietary protein

Dietary Supplement

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

Meal serving at low dietary protein

Dietary Supplement

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

Meal serving

Dietary Supplement

To investigate impact of habituated protein level

Primary outcomes

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

    Time frame: Baseline to 240 min postprandial

    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.

Secondary outcomes

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

    Time frame: Baseline to 240 min postprandial

    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 myofibrillar protein at 240 min.

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

    Time frame: Baseline to 240 min postprandial

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:

    From arterial and femoral venous blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments and concentrations as well as plasma flow will be measured.

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

    Time frame: Baseline to 240 min postprandial

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:

    From hepatic venous blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments and concentrations as well as plasma flow will be measured. Knowing the amount of ingested protein and labeled phenylalanine we can calculate the first pass splanchnic amino acid extraction.

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

    Time frame: Baseline to 240 min postprandial

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:

    From blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments will be measured.

  5. The myofibrillar protein fractional synthesis rate

    Time frame: Baseline to 240 min postprandial

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:

    From muscle biopsies obtained at baseline, 60 and 240 min the abundance of phenylalanine tracer bound in the myofibrillar proteins will be measured and the fractional synthesis rate will be measured within the first from baseline to 60 min and 240 min as well as from 60-240 min postprandial.

  6. Response of expression of proteins involved in muscle protein turnover

    Time frame: Baseline, 60 min and 240 min postprandial

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:

    From baseline to 60 and 240 min after intake of the standardized meal after 21 days of habituation to either a high or a low dietary protein intake expression of signalling proteins related to protein turnover in the muscle will be measured by use of western blotting.

  7. Urea production.

    Time frame: Baseline to 240 min postprandial

    Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:

    From blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min urea tracer enrichments and concentrations will be measured. With this, and flow measurements, we can determine the rate of urea production.

  8. Nitrogen and creatinine excreted in urine

    Time frame: 21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day

    Related to the adaptation to the 21 day habituation period to either high or low protein in the diet as well as the response to the standardized trial meal:

    Nitrogen and creatinine content is measured in urine is collected for the last 24 h of the 21 day habituation period, as well as during the 240 min trial day and the remaining 20 hours of the trial day.

  9. Fecal microbiota composition

    Time frame: Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21)

    Related to the adaptation to the 21 day habituation period to either high or low protein in the diet as well as the response to the standardized trial meal:

    The microbiota compositions, will be measured in fecal samples collected before the 21 day habituation period, after the 21 day habituation periode, as well as after the 240 min trial day

  10. Adaptation of expression of proteins involved in muscle protein turnover

    Time frame: After 21 days of habituation to either a high or a low dietary protein intake.

    Related to the adaptation to the 21 day habituation period to either high or low protein in the diet:

    Biopsies taken following the two 21 day habituation period will, by use of western blotting, be analysed for expression of signalling proteins involved in muscle protein turnover.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization

Acronym: FONDAA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2015
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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