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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
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

November 3, 2011
October 22, 2012
November 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01473576 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Protein Synthetic Rate
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
December 2012
December 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
Male
70 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01473576
11-3-057
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