Amino Acids

, Volume 50, Issue 9, pp 1215–1229 | Cite as

Safety of dietary supplementation with arginine in adult humans

  • Catherine J. McNeal
  • Cynthia J. Meininger
  • Colin D. Wilborn
  • Carmen D. Tekwe
  • Guoyao WuEmail author
Original Article


Previous studies with animals and humans have shown beneficial effects of dietary supplementation with l-arginine (Arg) on reducing white fat and improving health. At present, a long-term safe level of Arg administration to adult humans is unknown. The objective of this study was to conduct a randomized, placebo-controlled, clinical trial to evaluate the safety and tolerability of oral Arg in overweight or obese but otherwise healthy adults with a body mass index of ≥ 25 kg/m2. A total of 142 subjects completed a 7-day wash-in period using a 12 g Arg/day dose. All the remaining eligible 101 subjects who tolerated the wash-in dose (45 men and 56 women) were assigned randomly to ingest 0, 15 or 30 g Arg (as pharmaceutical-grade Arg-HCl) per day for 90 days. Arg was taken daily in at least two divided doses by mixing with a flavored beverage. At Days 0 and 90, blood pressures of study subjects were recorded, their physical examinations were performed, and their blood and 24-h urine samples were obtained to measure: (1) serum concentrations of amino acids, glucose, fatty acids, and related metabolites; and (2) renal, hepatic, endocrine and metabolic parameters. Our results indicate that the serum concentration of Arg in men or women increased (P < 0.05) progressively with increasing oral Arg doses from 0 to 30 g/day. Dietary supplementation with 30 g Arg/day reduced (P < 0.05) systolic blood pressure and serum glucose concentration in females, as well as serum concentrations of free fatty acids in both males and females. Based on physiological and biochemical variables, study subjects tolerated oral administration of 15 and 30 g Arg/day without adverse events. We conclude that a long-term safe level of dietary Arg supplementation is at least 30 g/day in adult humans.


Arginine Health Nutrition Obesity Safety Supplementation 



Alanine transaminase




Aspartate transaminase


Body mass index


Body weight




Nitric oxide


Observed safe level


Thyroid stimulating hormone



We thank staff nurses at Baylor Scott & White Hospital, as well as Gilson D. Honvoh, Shengdi Hu, Katherine Kelly, Faqiang Liu, Yuanyuan Luan, Gayan I. Nawaratna, and Tapasree R. Sarkar for assistance in this study. This work was supported by a grant from International Council of Amino Acid Science (Brussels, Belgium).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical statement

This study was approved by Baylor Scott & White Hospital and Texas A&M University Institutional Review Boards.

Informed consent

Informed consent was obtained from all study subjects.

Supplementary material

726_2018_2594_MOESM1_ESM.docx (33 kb)
Supplementary material 1 (DOCX 32 kb)
726_2018_2594_MOESM2_ESM.docx (33 kb)
Supplementary material 2 (DOCX 32 kb)


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Copyright information

© Springer-Verlag GmbH Austria, part of Springer Nature 2018

Authors and Affiliations

  • Catherine J. McNeal
    • 1
  • Cynthia J. Meininger
    • 2
  • Colin D. Wilborn
    • 3
  • Carmen D. Tekwe
    • 4
  • Guoyao Wu
    • 2
    • 5
    Email author
  1. 1.Department of Internal MedicineBaylor Scott & White HealthTempleUSA
  2. 2.Department of Medical Physiology, College of MedicineTexas A&M Health Science CenterTempleUSA
  3. 3.Department of Exercise and Sport ScienceUniversity of Mary Hardin-BaylorBeltonUSA
  4. 4.Department of Epidemiology and Biostatistics, School of Public HealthTexas A&M Health Science CenterCollege StationUSA
  5. 5.Department of Animal Science and Faculty of NutritionTexas A&M UniversityCollege StationUSA

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