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Completed

NCT Number: NCT05336994

Vitamin/Mineral Absorption From Two Different Supplements

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.

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Key information

Conditions

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivitamin/mineral supplement A

Dietary Supplement

Oral administration of Supplement A

Multivitamin/mineral supplement B

Dietary Supplement

Oral administration of Supplement B

Primary outcomes

  1. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum Vitamin A

  2. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum folate

  3. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum Vitamin D

  4. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum Vitamin B-12

  5. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of plasma Vitamin C

  6. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum zinc

  7. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum iron

  8. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum manganese

  9. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Total area-under-the-curve of serum magnesium

Secondary outcomes

  1. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of Vitamin A (mg/dL)

  2. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of folate (mg/dL)

  3. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of Vitamin D (mg/dL)

  4. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of Vitamin B-12 (mg/dL)

  5. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum plasma level of Vitamin C (mg/dL)

  6. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of zinc (mg/dL)

  7. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of iron (mg/dL)

  8. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of manganese (mg/dL)

  9. Assess the serum or plasma levels of five vitamins and four minerals

    Time frame: 6 hours

    Maximum serum level of magnesium (mg/dL)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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