Vitamin/Mineral Absorption From Two Different Supplements

NCT05336994 | Completed

• 1 other identifier: 1692409
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Nutrition

Keywords

Minerals; Vitamins; Absorption

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

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

  6 hours

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

  6 hours

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

  6 hours

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

  6 hours

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

  6 hours

Study Arms (2)

Multivitamin/mineral supplement A to B

EXPERIMENTAL

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; Dietary Supplement: Multivitamin/mineral supplement B

Multivitamin/mineral supplement B to A

EXPERIMENTAL

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; Dietary Supplement: Multivitamin/mineral supplement B

Interventions

Multivitamin/mineral supplement A DIETARY_SUPPLEMENT

Oral administration of Supplement A

Multivitamin/mineral supplement A to B; Multivitamin/mineral supplement B to A

Multivitamin/mineral supplement B DIETARY_SUPPLEMENT

Oral administration of Supplement B

Multivitamin/mineral supplement A to B; Multivitamin/mineral supplement B to A

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Geritol

Study Officials

• Robert M. Hackman, PhD

  Research Nutritionist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 20, 2022
• Study Start: April 29, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)