Vitamin/Mineral Absorption From Two Different Supplements

Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes

The objective of this project is to evaluate the postprandial serum and plasma vitamin and mineral levels in healthy adult men and women between 18 and 32 years of age, following a single intake of a multivitamin and mineral supplement processed in two different ways.

Study Overview

• Status: Completed
• Conditions: Healthy Nutrition
• Intervention / Treatment: Dietary supplement: Multivitamin/mineral supplement A; Dietary supplement: Multivitamin/mineral supplement B

Detailed Description

Serum or plasma levels of five vitamins and four minerals will be measured at baseline, and 1, 2, 4, and 6 hours after the intake of a multivitamin/mineral supplement processed by two different methods. The two methods involve using either conventional isolated vitamins and minerals blended together to provide approximately 100% of the Daily Value, or using the same amount of vitamins and minerals that have first been processing into liposomal forms before blending.

Participants are required to come for two study visits which are 5 to 7 days apart. Health screening will also be done at Study Visit 1. The order of supplement assignment will be randomized, performed in a double-blind manner.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Ragle Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and females 18-32 years of age
• BMI 18.5-32 kg/m2
• Free from disease
• Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician
• Normal blood pressure (individuals whose average blood pressure is greater than 140/90 will be excluded from the study)
• Suitable vein structure and access for successful placement of an indwelling catheter, as determined by our nurse phlebotomist

Exclusion Criteria:

• Alcohol consumption > 3 drinks/week (i.e., 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
• Smoking
• Vaping or using cannabis in any form
• Using multivitamin/mineral supplements in the past two months
• Currently taking supplements including botanical supplements, probiotics or fiber
• Fruit consumption ≥ 2 cups/day
• Vegetable consumption ≥ 3 cups/day
• Coffee/tea ≥ 3 cups/day
• Chronic/routine high-intensity exercise
• Any chronic health conditions
• Self-reported malabsorption
• Currently taking prescription drugs
• Indications of substance or alcohol abuse within the last 3 years
• Unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multivitamin/mineral supplement A to B; Participants will be randomly assigned to receive Supplement A and after 5-7 days of follow-up, they will receive Supplement B.	Dietary supplement: Multivitamin/mineral supplement A; Oral administration of Supplement A; Dietary supplement: Multivitamin/mineral supplement B; Oral administration of Supplement B
Experimental: Multivitamin/mineral supplement B to A; Participants will be randomly assigned to receive Supplement B and after 5-7 days of follow-up, they will receive Supplement A.	Dietary supplement: Multivitamin/mineral supplement A; Oral administration of Supplement A; Dietary supplement: Multivitamin/mineral supplement B; Oral administration of Supplement B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum Vitamin A	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum folate	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum Vitamin D	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum Vitamin B-12	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of plasma Vitamin C	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum zinc	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum iron	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum manganese	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Total area-under-the-curve of serum magnesium	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of Vitamin A (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of folate (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of Vitamin D (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of Vitamin B-12 (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum plasma level of Vitamin C (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of zinc (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of iron (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of manganese (mg/dL)	6 hours
Assess the serum or plasma levels of five vitamins and four minerals	Maximum serum level of magnesium (mg/dL)	6 hours

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Robert M. Hackman, PhD, Research Nutritionist

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Absorption; Vitamins; Minerals
• Other Study ID Numbers: 1692409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No