Healthy subjects Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adults 2. A normal body weight (body mass index (BMI) of 19–24.99 kg/m2) 3. Recreationally active (according to American College of Sports Medicine Guidelines)
Exclusion criteria
Exclusion criteria: 1. Currently being treated for or diagnosed with a gastrointestinal, cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder 2. Participants determined to not be weight stable defined as measured body mass deviating by 2% or more 3. Participants not willing to abstain from alcohol, nicotine, and caffeine for 12 hours before each visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure in this study is plasma zinc levels measured using inductively coupled plasma/mass spectrometry (ICP/MS) at baseline, and 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420- and 480-minutes post-ingestion as mcg/dL. The zinc concentrations are used to calculate: 1. Incremental area under the concentration versus time curve (iAUC) as mcg/dL * 480 minutes 2. Maximum observed concentration (Cmax) as mcg/dL 3. The time of maximum observed concentration (Tmax) as minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events measured using the GI Health questionnaire evaluating and ranking stomach ache, abdominal pain or cramps, bloating, subjective impression of rectal gas excretion and nausea side effects on a scale from 0 (no symptoms) to 5 (severe symptoms) before and 480 minutes post-ingestion. In addition, participants will be asked to rank the severity of dizziness, headache, fast or racing heart rate, heart skipping or palpitations, shortness of breath, nervousness, blurred vision, and other unusual or adverse effects on a scale from 0 (none) to 5 (very severe). | — |
Countries
United States of America