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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Muscle Protein Synthesis

Treatments: Dietary Supplement: Sodium chloride; Dietary Supplement: Nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01473576

11-3-057

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 2 patient groups, including a placebo group

Nitrate

Experimental group

Description:

Sodium nitrate ingestion prior to ingesting intrinsically labeled protein

Treatment:

Dietary Supplement: Nitrate

Sodium chloride

Placebo Comparator group

Description:

Sodium chloride placebo group

Treatment:

Dietary Supplement: Sodium chloride