Vitamin/Mineral Absorption From Two Different Supplements

NCT ID: NCT05336994

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2022-07-30

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.

Conditions

Healthy Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multivitamin/mineral supplement A

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of Supplement A

Multivitamin/mineral supplement B

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of Supplement B

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.

Group Type: EXPERIMENTAL

Multivitamin/mineral supplement A

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of Supplement A

Multivitamin/mineral supplement B

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of Supplement B

Interventions

Multivitamin/mineral supplement A

Oral administration of Supplement A

Intervention Type: DIETARY_SUPPLEMENT

Multivitamin/mineral supplement B

Oral administration of Supplement B

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 32 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M. Hackman, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Nutritionist

Locations

Ragle Human Nutrition Research Center

Davis, California, United States

Countries

United States

Other Identifiers

1692409

Identifier Type: -

Identifier Source: org_study_id