Safety of Graded-Dose of Histidine in Humans

Completed · Not applicable

Conditions studied: Healthy

In brief

Histidine is an essential amino acid with health benefits that include anti-inflammatory, anti-oxidant, glucoregulatory, and weight management. The current expert opinion for histidine intake is 8 and 12 mg/(kg body weight per day), an estimate that was extrapolated from the infant requirement for histidine. Further, the clinical safety of histidine supplementation above the average dietary intake has not been determined.The overarching objectives are to 1) measure the safety of histidine supplementation and 2) measure the potential benefits of histidine at doses above the average intake and current recommendation in a healthy adult population.

Key facts

Study ID

NCT04142294

Run by

Cornell University

People needed

40

Starts

2017-09-21

Expected to finish

2019-08-31

Last updated by the study team

2022-02-07

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy young males and females aged 21-50 y.

You may not qualify if…

• A body-mass index (BMI) <19.9 kg/m2 or > 29.9 kg/m2
• taking/on immunosuppressive medications or prescription anti-coagulation therapy
• pregnancy
• breastfeeding
• musculoskeletal disorder
• diabetes
• alcoholism (>11 drinks per week for women, >14 drinks per week for men) or other drug addiction
• acute illness
• inability to travel to Cornell University campus
• A blood pressure at or above 140/90
• For individuals desiring to participate in the optional biopsy, a history of a negative or allergic reaction to local anesthetic is an exclusion criteria

Where it is running

• Human Metabolic Research Unit — Ithaca, New York, United States

Full record on ClinicalTrials.gov

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