Healthy NutritionNCT05336994
Vitamin/Mineral Absorption From Two Different Supplements
A study testing Multivitamin/mineral supplement A and Multivitamin/mineral supplement B in people with Healthy Nutrition, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- Multivitamin/mineral supplement A and Multivitamin/mineral supplement B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes
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.
Read the 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
- Being tested
- Multivitamin/mineral supplement A, Multivitamin/mineral supplement B
- Keywords
- Minerals, Vitamins, Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin/mineral supplement ADietary supplement
Oral administration of Supplement A
Multivitamin/mineral supplement BDietary supplement
Oral administration of Supplement B
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Multivitamin/mineral supplement A; Dietary Supplement: Multivitamin/mineral supplement B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum Vitamin A
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum folate
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum Vitamin D
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum Vitamin B-12
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of plasma Vitamin C
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum zinc
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum iron
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum manganese
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Total area-under-the-curve of serum magnesium
Measured: 6 hours
Secondary outcomes (9)
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of Vitamin A (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of folate (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of Vitamin D (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of Vitamin B-12 (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum plasma level of Vitamin C (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of zinc (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of iron (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of manganese (mg/dL)
Measured: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Maximum serum level of magnesium (mg/dL)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start29 Apr 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M. Hackman, PhD, Principal investigator, Research Nutritionist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336994
- Sponsor's protocol ID
- 1692409
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Plasma Vitamins and Minerals Following Intake of a Multivitamin/ Mineral Formula Produced by Two Different Manufacturing Processes
- ClinicalTrials.gov ID
- NCT05336994
- Acronym / sponsor ID
- 1692409
- Conditions
- Healthy Nutrition
- Keywords
- Minerals, Vitamins, Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multivitamin/mineral supplement A to B | Experimental | Dietary Supplement: Multivitamin/mineral supplement A, Dietary Supplement: Multivitamin/mineral supplement BParticipants will be randomly assigned to receive Supplement A and after 5-7 days of follow-up, they will receive Supplement B. |
| Multivitamin/mineral supplement B to A | Experimental | Dietary Supplement: Multivitamin/mineral supplement A, Dietary Supplement: Multivitamin/mineral supplement BParticipants will be randomly assigned to receive Supplement B and after 5-7 days of follow-up, they will receive Supplement A. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivitamin/mineral supplement AOral administration of Supplement A | Dietary supplement | Multivitamin/mineral supplement A to B, Multivitamin/mineral supplement B to A |
| Multivitamin/mineral supplement BOral administration of Supplement B | Dietary supplement | Multivitamin/mineral supplement A to B, Multivitamin/mineral supplement B to A |
Primary outcome
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
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Total area-under-the-curve of serum folate
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
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
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
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Total area-under-the-curve of serum zinc
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Total area-under-the-curve of serum iron
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Total area-under-the-curve of serum manganese
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Total area-under-the-curve of serum magnesium
9 secondary outcomes
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Assess the serum or plasma levels of five vitamins and four minerals
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M. Hackman, PhD principal investigator
Research Nutritionist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multivitamin/mineral supplement A and Multivitamin/mineral supplement B in people with Healthy Nutrition, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the serum or plasma levels of five vitamins and four minerals (time frame: 6 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.