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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473576
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : April 15, 2016
Information provided by (Responsible Party):
Maastricht University Medical Center

November 3, 2011
November 17, 2011
April 15, 2016
August 2011
July 2012   (Final data collection date for primary outcome measure)
Muscle protein fractional synthetic rate [ Time Frame: -2, 0, +2, +5 h during the trial ]
Muscle protein fractional synthetic rate assessed using the muscle biopsy technique.
Same as current
Complete list of historical versions of study NCT01473576 on Archive Site
  • Plasma amino acids [ Time Frame: every 30 min (from -2 h to + 5 h during the test day) ]
    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) ]
    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.
Same as current
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Impact of Nitrate Ingestion on Protein Synthesis
The Impact of Dietary Nitrate Ingestion on Muscle Protein Synthesis in Elderly Type II Diabetics
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Muscle Protein Synthesis
  • Dietary Supplement: Nitrate
    0.15 mmol/kg body weight sodium nitrate (dissolved in 250 mL water)
  • Dietary Supplement: Sodium chloride
    0.15 mmol sodium chloride dissolved in 250 mL water.
  • Experimental: Nitrate
    Sodium nitrate ingestion prior to ingesting intrinsically labeled protein
    Intervention: Dietary Supplement: Nitrate
  • Placebo Comparator: Sodium chloride
    Sodium chloride placebo group
    Intervention: Dietary Supplement: Sodium chloride
Kouw IW, Gorissen SH, Burd NA, Cermak NM, Gijsen AP, van Kranenburg J, van Loon LJ. Postprandial Protein Handling Is Not Impaired in Type 2 Diabetes Patients When Compared With Normoglycemic Controls. J Clin Endocrinol Metab. 2015 Aug;100(8):3103-11. doi: 10.1210/jc.2015-1234. Epub 2015 Jun 2.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
70 Years to 85 Years   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Study Director: Luc van Loon, PhD Maastricht University
Maastricht University Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP