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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

Brief Summary:
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 or disease Intervention/treatment Phase
Muscle Protein Synthesis Dietary Supplement: Nitrate Dietary Supplement: Sodium chloride Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: The Impact of Dietary Nitrate Ingestion on Muscle Protein Synthesis in Elderly Type II Diabetics
Study Start Date : August 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01473576

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center Identifier: NCT01473576     History of Changes
Other Study ID Numbers: 11-3-057
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: October 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht University Medical Center:
type II diabetes
protein synthesis