Fermented zinc improves bioavailability

Not Applicable

Completed

Conditions: Healthy subjects
Not Applicable

Registration Number: ISRCTN67008850

Lead Sponsor: Ashland Specialty Ingredients G.P.

Brief Summary: 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38613045/ (added 17/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>The zinc concentrations are used to calculate:<br>1. Incremental area under the concentration versus time curve (iAUC) as mcg/dL * 480 minutes<br>2. Maximum observed concentration (Cmax) as mcg/dL<br>3. The time of maximum observed concentration (Tmax) as minutes<br>

Secondary Outcome Measures

Name	Time	Method
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).