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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01473576
Acronym
PRO-Nitrate
Enrollment
25
Registered
2011-11-17
Start date
2011-08-31
Completion date
2013-12-31
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Protein Synthesis

Keywords

type II diabetes, protein synthesis, nitrate, elderly

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.

Interventions

DIETARY_SUPPLEMENTNitrate

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

DIETARY_SUPPLEMENTSodium chloride

0.15 mmol sodium chloride dissolved in 250 mL water.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
70 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Muscle protein fractional synthetic rate-2, 0, +2, +5 h during the trialMuscle protein fractional synthetic rate assessed using the muscle biopsy technique.

Secondary

MeasureTime frameDescription
Plasma amino acidsevery 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 nitrateevery 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026