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Impact of Nitrate Ingestion on Protein Synthesis (PRO-Nitrate)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01473576
First received: November 3, 2011
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

A diet rich in leafy green vegetables has been shown to reduce the risk of developing chronic metabolic disease. The health benefits from these particular vegetables may be attributed to their high nitrate content. Recent work suggests that dietary nitrate triggers endogenous nitric oxide release, thereby stimulating vasodilation and improving muscle perfusion in an insulin-independent manner. We hypothesize that in an insulin-resistant state, nitrate co-ingestion will increase muscle perfusion, thereby improving post-prandial delivery of nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of food derived amino acids will stimulate post-prandial muscle protein synthesis and, as such, compensate for a blunted muscle protein synthetic response to food intake in the elderly. This proposal will investigate the efficacy of nitrate co-ingestion as a means to augment muscle protein synthesis in elderly, type 2 diabetes patients and may lead to a novel therapy in the clinical care of type 2 diabetes patients.


Condition Intervention
Protein Synthetic Rate
 Dietary Supplement: Nitrate
Dietary Supplement: Sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Impact of Dietary Nitrate Ingestion on Muscle Protein Synthesis in Elderly Type II Diabetics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Muscle protein fractional synthetic rate [ Time Frame: -2, 0, +2, +5 h during the trial ] [ Designated as safety issue: No ]
    Muscle protein fractional synthetic rate assessed using the muscle biopsy technique.


Secondary Outcome Measures:
  • Plasma amino acids [ Time Frame: every 30 min (from -2 h to + 5 h during the test day) ] [ Designated as safety issue: No ]
    Blood sampling will occur through a catheter placed in an anticubital vein every 30 minutes throughout the test day. We will be using this plasma to measure plasma amino acids to determine the enrichment of labeled amino acids from both the IV tracer and the intrinsically-labeled casein protein. We wish to track the changes in amino acids from the intrinsically-labeled casein protein.

  • Plasma nitrate [ Time Frame: every 30 min (from -2 h to + 5 h during the test day) ] [ Designated as safety issue: No ]
    Plasma nitrate will be measured every 30 minutes during the test day through blood sampling from the catheter inserted into an antecubital vein. We want to measure the changes in plasma nitrate after consuming the nitrate or placebo beverage.


Enrollment: 25
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitrate
Sodium nitrate ingestion prior to ingesting intrinsically labeled protein
 Dietary Supplement: Nitrate
0.15 mmol/kg body weight sodium nitrate (dissolved in 250 mL water)
Placebo Comparator: Sodium chloride
Sodium chloride placebo group
 Dietary Supplement: Sodium chloride
0.15 mmol sodium chloride dissolved in 250 mL water.

  Eligibility

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Aged between 70-85 years
  • BMI < 30 kg/m2
  • Non insulin-dependent diabetes mellitus type 2 patients (T2DM) ( >1 y since diagnoses)

Exclusion Criteria:

  • Smoking
  • Hypertension (according to WHO criteria)[29] and/or cardiovascular disease treated with medication containing nitrates and/or having vasodilatory effects
  • Use of medication, except for oral blood glucose lowering medication
  • Use of insulin
  • All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • HbA1c > 10.0% (86 mmol/mol)
  • Donated blood in last 3 months
  • Diagnosed impaired renal or liver function
  • Myocardial infarction within the last 3 years
  • Gastric acid inhibitors
  • Use of anti-coagulants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473576

Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Luc van Loon, PhD Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01473576     History of Changes
Other Study ID Numbers: 11-3-057
Study First Received: November 3, 2011
Last Updated: October 22, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
type II diabetes
protein synthesis
nitrate
elderly

ClinicalTrials.gov processed this record on May 21, 2013