Vitamin/Mineral Absorption From Two Different Supplements

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Nutrition

Intervention / Treatment
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* Dietary Supplement: Multivitamin/mineral supplement A
* Dietary Supplement: Multivitamin/mineral supplement B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomly assigned to receive either supplement A or supplement B during the first visit. Five to seven days later, participants will receive the other supplement.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivitamin/mineral supplement A to B<br>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<br>* Oral administration of Supplement A<br>Dietary Supplement: Multivitamin/mineral supplement B<br>* Oral administration of Supplement B<br>|
| Experimental: Multivitamin/mineral supplement B to A<br>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<br>* Oral administration of Supplement A<br>Dietary Supplement: Multivitamin/mineral supplement B<br>* Oral administration of Supplement B<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minerals, Vitamins, Absorption