Clinical trial NCT05336994: Vitamin/Mineral Absorption From Two Different Supplements
Official title: Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Nutrition
Keywords: Minerals
Vitamins
Absorption
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
Secondary outcomes:
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
measure: Assess the serum or plasma levels of five vitamins and four minerals
timeFrame: 6 hours
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center
state: California
Study officials:
affiliation: Research Nutritionist
name: Robert M. Hackman, PhD
role: PRINCIPAL_INVESTIGATOR
References: