Impact of Nitrate Ingestion on Protein Synthesis

Muscle Protein Synthesis Clinical Trial

— PRO-Nitrate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473576
• Other study ID #: 11-3-057
• Status: Completed
• Phase: N/A
• First received: November 3, 2011
• Last updated: April 14, 2016
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Muscle Protein Synthesis

Intervention

Dietary Supplement:
• Nitrate
0.15 mmol/kg body weight sodium nitrate (dissolved in 250 mL water)
• Sodium chloride
0.15 mmol sodium chloride dissolved in 250 mL water.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein fractional synthetic rate	Muscle protein fractional synthetic rate assessed using the muscle biopsy technique.	-2, 0, +2, +5 h during the trial	No
Secondary	Plasma amino acids	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.	every 30 min (from -2 h to + 5 h during the test day)	No
Secondary	Plasma nitrate	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.	every 30 min (from -2 h to + 5 h during the test day)	No