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Vitamin/Mineral Absorption From Two Different Supplements

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT05336994
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.8
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Multivitamin/mineral supplement A
  • Dietary Supplement: Multivitamin/mineral supplement B
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes
Actual Study Start Date :
Apr 29, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 24, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

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

  2. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Total area-under-the-curve of serum folate

  3. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

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

  4. Assess the serum or plasma levels of five vitamins and four minerals [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 [6 hours]

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

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

    Total area-under-the-curve of serum zinc

  7. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Total area-under-the-curve of serum iron

  8. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Total area-under-the-curve of serum manganese

  9. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Total area-under-the-curve of serum magnesium

Secondary Outcome Measures

  1. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum serum level of Vitamin A (mg/dL)

  2. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum serum level of folate (mg/dL)

  3. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum serum level of Vitamin D (mg/dL)

  4. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

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

  5. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum plasma level of Vitamin C (mg/dL)

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

    Maximum serum level of zinc (mg/dL)

  7. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum serum level of iron (mg/dL)

  8. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum serum level of manganese (mg/dL)

  9. Assess the serum or plasma levels of five vitamins and four minerals [6 hours]

    Maximum serum level of magnesium (mg/dL)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 32 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ragle Human Nutrition Research Center Davis California United States 95616

Sponsors and Collaborators

  • University of California, Davis

Investigators

  • Principal Investigator: Robert M. Hackman, PhD, Research Nutritionist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT05336994
Other Study ID Numbers:
  • 1692409-1
First Posted:
Apr 20, 2022
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of California, Davis
Minerals
Vitamins
Absorption

Study Results

No Results Posted as of May 11, 2022