Bioavailability of Select Nutrients From Two Formulations of a Multivitamin/Mineral Supplement

NCT05646368 | Completed

• 1 other identifier: MB-2113
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the relative bioavailability of select nutrients from two formulations of a multivitamin/mineral supplement in healthy adults.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (1)

• Baseline-adjusted geometric mean ratio (GMR) for area under the curve (AUC) from 0 to 2 h for plasma folate

  Changes in GMR for baseline-adjusted AUC for plasma folate

  Baseline to 2 hours

Secondary Outcomes (7)

• Unadjusted and baseline-adjusted AUC from 0 to 2 h for select nutrients in plasma

  Baseline to 2 hours

• Unadjusted and baseline-adjusted GMRs for AUC from 0 to 2 h for select nutrients in plasma

  Baseline to 2 hours

• Unadjusted and baseline-adjusted AUC from 0 to 8 h for select nutrients in plasma

  Baseline to 8 hours

• Unadjusted and baseline-adjusted GMRs for AUC from 0 to 8 h for select nutrients in plasma

  Baseline to 8 hours

• Maximum concentrations of select nutrients in plasma

  Baseline to 8 hours

Study Arms (2)

Formulation #1 of a multivitamin/mineral supplement

EXPERIMENTAL

Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement

Dietary Supplement: Formulation #1

Formulation #2 of a multivitamin/mineral supplement

ACTIVE COMPARATOR

Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement

Dietary Supplement: Formulation #2

Interventions

Formulation #1 DIETARY_SUPPLEMENT

Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement

Formulation #1 of a multivitamin/mineral supplement

Formulation #2 DIETARY_SUPPLEMENT

Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement

Formulation #2 of a multivitamin/mineral supplement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is male or female, 18 to 45 years of age, inclusive.
• Subject has a BMI of ≥18.50 and \<30.00 kg/m2.
• Subject is a non-smoker (at least 6 months) and has no plans to start smoking (or vaping) during the study period.
• Subject is judged to be in good health based on medical history and routine laboratory tests.
• Subject has a score of ≥7 on the Vein Access Scale.
• Subject agrees to abstain from alcohol consumption and vigorous physical activity for at least 24 h prior to all test visits.
• Subject understands the study procedures, and is willing to complete them, and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

You may not qualify if:

• Individual has a history of difficulty swallowing capsules or large pills.
• Individual has a serum folate concentration outside of the normal range (\>3.0 ng/ml) at visit 1, day -7.
• Individual has a serum zinc concentration outside of the normal range (44-115 μg/dL) on visit 1, day -7.
• Individual has a serum magnesium concentration outside of the normal range (1.6 - 2.3 mg/dL) on visit 1, day -7.
• Individual has a serum vitamin B12 concentration outside of the normal range (232-1245 pg/mL) on visit 1, day -7.
• Individual has a hemoglobin outside of the normal range (13.0-17.7 g/dL).
• Individual has had a blood transfusion during the 3 months prior to the screening visit (visit 1, day -7).
• Individual has any gastrointestinal condition that would potentially interfere with absorption of the study product (e.g., inflammatory bowel disease, celiac disease, history of gastric bypass surgery, chronic gastritis).
• Individual has a history or presence of clinically important medical diagnosis, in the opinion of the Principal Investigator.
• Individual has an active infection or sign/symptoms of an infection. The test days (visits 2-5) will be rescheduled to allow the subject to be symptom-free of any type of systemic infection for at least five days.
• Individual has recent use of antibiotics (within 7 days of visit 2, day 0) and throughout the study period. The test days will be rescheduled to allow the subject to wash out the antibiotic for at least 7 days.
• Individual has unstable use (initiation or change in dose) within four weeks of visit 2 (day 0) of antihypertensive medications, thyroid hormone replacement, hormonal contraceptives, or hormone therapy.
• Individual has consumed any dietary supplements (including all vitamin/mineral supplements) within one week of visit 2, day 0 and throughout the study period.
• Individual has received an intramuscular injection of vitamin B12 within 6 months of visit 2, day 0.
• Subject is female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Pharmavite LLC: collaborator

Study Sites (1)

Health Awareness

Port Saint Lucie, Florida, 34952, United States

Location

MeSH Terms

Interventions

Akacid-medical-formulation

Study Officials

• Kevin C Maki, PhD

  MB Clinical Research & Consulting

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: December 23, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)