Impact of Nitrate Ingestion on Protein Synthesis

NCT ID: NCT01473576

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Muscle Protein Synthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Nitrate

Sodium nitrate ingestion prior to ingesting intrinsically labeled protein

Group Type: EXPERIMENTAL

Nitrate

Intervention Type: DIETARY_SUPPLEMENT

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

Sodium chloride

Sodium chloride placebo group

Group Type: PLACEBO_COMPARATOR

Sodium chloride

Intervention Type: DIETARY_SUPPLEMENT

0.15 mmol sodium chloride dissolved in 250 mL water.

Interventions

Nitrate

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

Intervention Type: DIETARY_SUPPLEMENT

Sodium chloride

0.15 mmol sodium chloride dissolved in 250 mL water.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luc van Loon, PhD

Role: STUDY_DIRECTOR

Maastricht University

Locations

Maastricht University

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.

Reference Type: DERIVED

PMID: 32069356 (View on PubMed)

Kouw IW, Gorissen SH, Burd NA, Cermak NM, Gijsen AP, van Kranenburg J, van Loon LJ. Postprandial Protein Handling Is Not Impaired in Type 2 Diabetes Patients When Compared With Normoglycemic Controls. J Clin Endocrinol Metab. 2015 Aug;100(8):3103-11. doi: 10.1210/jc.2015-1234. Epub 2015 Jun 2.

Reference Type: DERIVED

PMID: 26037513 (View on PubMed)

Other Identifiers

11-3-057

Identifier Type: -

Identifier Source: org_study_id