Fermented zinc improves bioavailability
| ISRCTN | ISRCTN67008850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67008850 |
| Secondary identifying numbers | GPM Zinc |
- Submission date
- 31/01/2024
- Registration date
- 12/02/2024
- Last edited
- 17/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study arms
Glycoprotein matrix (GPM) nutrients are produced from a nutrient-dense broth which is cultured and bio-transformed via glycosylation by microorganisms such as yeast and/or probiotics into an advanced nutrient bound to a food source that becomes more bioavailable. This study investigates the effects of GPM on the absorption of zinc, compared to zinc oxide, commonly used as a dietary supplement.
Who can participate?
Male and female healthy volunteers, 18-55 years of age
What does the study involve?
The study involved the ingestion of the study material (GPM zinc or zinc oxide) followed by multiple blood draws.
Where is the study run from?
University of Mary Hardin-Baylor, Belton, TX, USA
When is the study starting and how long is it expected to run for?
July 2023 to January 2024
Who is funding the study?
Ashland, Kearny, NJ, USA
Who is the main contact?
Prof. Lem Taylor, University of Mary Hardin-Baylor, ltaylor@umhb.edu
Contact information
Public, Scientific, Principal Investigator
900 College Street
Belton
76513
United States of America
| Phone | +1-254-295-4895 |
|---|---|
| ltaylor@umhb.edu |
Study information
| Study design | Single-center interventional randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Glycoprotein matrix zinc exhibits improved absorption: a randomized crossover trial |
| Study acronym | GPM Zinc |
| Study objectives | The overall purpose of this study was to compare the effects of glycoprotein matrix-bound nutrients on the bioavailability of inorganic zinc oxide, commonly used as a dietary ingredient. We hypothesized that fermentation would result in greater absorption and appearance in the blood following acute ingestion while potentially reducing the incidents of gastrointestinal distress. |
| Ethics approval(s) |
Approved 04/10/2023, Institutional Review Board of the University of Mary Hardin-Baylor (900 College Street, Belton, TX, 76513, United States of America; +1-254-295-4553; abaggett@umhb.edu), ref: 267 |
| Health condition(s) or problem(s) studied | Healthy subjects |
| Intervention | Following baseline sampling, participants ingested their respective supplements with 350 mL of cold water. Blood samples will be taken at 30-, 60-, 90-, 120-, 180-, 240-, 300-, 360-, 420- and 480-minutes post-ingestion. Both zinc treatments, GPM (220mg GPM™ Soy-Free Zinc (GPM) containing 5% zinc, Ashland, Kearny, NJ, USA) and USP (zinc oxide) contained the equivalent of 11mg of zinc, 100% of the daily value and will be administered in the form of one uncoated tablet. Subjects will be randomized using random.org. A 1-week wash-out period will be implemented before subjects are crossed over to the other supplement and repeated the experimental procedure. |
| Intervention type | Supplement |
| Primary outcome measure | 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 outcome measures | 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). |
| Overall study start date | 01/07/2023 |
| Completion date | 03/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 16 |
| Total final enrolment | 16 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 05/10/2023 |
| Date of final enrolment | 05/11/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Belton
76513
United States of America
Sponsor information
Industry
8145 Blazer Drive
Wilmington, DE
19808
United States of America
| Phone | +1-732-331-2554 |
|---|---|
| Himanshu.Patel@ashland.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from the principal investigator, Prof. Lem Taylor, ltaylor@umhb.edu. The raw data is available and can be shared upon written request, if the request is reasonable, as determined by the principal investigator. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/03/2024 | 17/05/2024 | Yes | No |
Editorial Notes
17/05/2024: Publication reference added.
05/02/2024: Studies existence confirmed by the Institutional Review Board of the University of Mary Hardin-Baylor.
