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Completed

NCT Number: NCT01473576

Impact of Nitrate Ingestion on Protein Synthesis

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.

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Key information

Conditions

Muscle Protein Synthesis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

70 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Nitrate

Dietary Supplement

0.15 mmol/kg body weight sodium nitrate (dissolved in 250 mL water)

Sodium chloride

Dietary Supplement

0.15 mmol sodium chloride dissolved in 250 mL water.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Impact of Dietary Nitrate Ingestion on Muscle Protein Synthesis in Elderly Type II Diabetics

Acronym: PRO-Nitrate

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 17, 2011
Registry last updated
Apr 15, 2016

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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