In healthy adults does a novel liposomal multivitamin/mineral enhance absorption compared to a "food-based" multivitamin/mineral or standard USP multivitamin/mineral product?
| ISRCTN | ISRCTN61456591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61456591 |
| Secondary identifying numbers | LIPMULT-0002 |
- Submission date
- 29/09/2022
- Registration date
- 04/10/2022
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Dietary intervention studies among firefighters have shown improvements to oxidative stress markers that play a Multivitamin/mineral (MVM) supplements have been consumed since the early 1940s and remain one of the most popular dietary supplement categories today. Continual innovation is needed to establish products which deliver optimal doses of key vitamins, minerals, and botanicals in the most effective manner. A particularly notable development is the introduction of liposomal delivery mechanisms used to enhance absorption and maximize benefits to the consumer and have long been used as a drug delivery mechanism. Liposomes can accommodate both water-soluble and fat-soluble components and are well suited for use with the diverse properties of the vitamins and minerals contained in an MVM product. As compared to traditional methods, liposomal delivery may result in greater stability within the gastrointestinal tract, increased absorption, and ultimately greater intracellular delivery of nutrients. Despite the immense promise of this technology in general, additional research is needed to clarify the pharmacokinetic properties of specific, novel liposomal MVM formulations. Based on the favorable properties of liposomes for nutrient delivery, it is hypothesized that the liposomal MVM will exhibit greater bioavailability as indicated by higher circulating concentrations of representative micronutrients (i.e., water- and fat-soluble vitamins and minerals) when compared to a traditional MVM.
Who can participate?
Healthy volunteers aged 18 to 65 years
What does the study involve?
Phone Screening: Prospective participants will first undergo a phone screening to determine general eligibility using a standard phone script. If this screening suggests they may be a good candidate, they will be invited to a familiarization session. Familiarization: During the familiarization, participants will be informed about the study and sign informed consent statements in compliance with the University IRB. Participants will respond to health history questionnaires; undergo a general health screening including having their height, weight, and resting heart rate and blood pressure determined; and, be informed of the general methods of the study.
Experimental 1 Testing: Participants will report to the lab after a 12 hour fast from food, dietary supplements, medications, and intake of all substances except water. Participants donate a fasting blood sample of approximately four teaspoons (~20 milliliters) of venous blood and then consume the assigned supplement along with a standardized breakfast. Blood samples will be taken 2, 4, and 6 hours following ingestion of the meal and supplement. Samples will be processed and stored at -20◦C until shipment. Washout Period. Participants will observe at least a 7-day washout period.
Experiment 2 Testing: Participants will report to the lab in a fasted state and repeat the experiment while consuming the next randomly assigned treatment. Washout Period. Participants will observe at least a 7-day washout period. Experiment 3 Testing: Participants will report to the lab in a fasted state and repeat the experiment while consuming the final randomly assigned treatment.
What are the possible benefits and risks of participating?
Benefits: Possible benefits of participating include determining if nutrient absorption is enhanced when a MVM supplement utilizes a novel liposomal delivery mechanism.
Risks: Possible risks of participating include slight pain when the needle is inserted during the phlebotomy procedures. Participants may develop a harmless black and blue mark, and their arm may be sore. Occasionally, some people feel dizzy or lightheaded when blood is drawn. They may become sweaty, feel cold or tingly, and may faint or throw up. Risks that are possible but unlikely include infection, nerve damage, and puncturing an artery instead of a vein. However, only a trained phlebotomist will be performing blood sampling using sterile procedures. Side effects of large doses of multivitamins may include tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion and muscle weakness or limp feeling. When taken as directed, multivitamins and minerals are not expected to cause serious side effects.
Where is the study run from?
Texas A&M University (USA)
When is the study starting and how long is it expected to run for?
January 2022 for 1 month
Who is funding the study?
Better Being Company (USA)
Who is the main contact?
Dr Richard Kreider, rbkreider@tamu.edu
Contact information
Principal Investigator
400 Bizzell St
College Station
77843
United States of America
| Phone | +1 979.458.1498 |
|---|---|
| rbkreider@tamu.edu |
Study information
| Study design | Randomized placebo controlled double-blinded triple-arm crossover intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | School |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pharmacokinetic analysis of nutrient absorption from a novel liposomal multivitamin/mineral formulation |
| Study hypothesis | A novel liposomal MVM (multivitamin/mineral) improves absorption and pharmacokinetics when compared to standard USP & "food-based" MVM. |
| Ethics approval(s) | Approved 05/01/2022, Texas A&M IRB (General Services Complex (GSC), Room 101A, 750 Agronomy Road, College Station, TX, 77843-1186, USA; +1 979-458-4067; irb@tamu.edu), ref: IRBID: IRB2021-1418, Study Ref# 131667 |
| Condition | Pharmacokinetics of multivitamins in healthy adults |
| Intervention | Approximately 40 participants will be recruited with a goal of completing 25 in the study. Familiarization: During the familiarization, participants will be informed about the study and sign informed consent statements in compliance with the University IRB. Participants will respond to health history questionnaires; undergo a general health screening including having their height, weight, and resting heart rate and blood pressure determined; and, be informed of the general methods of the study. Experimental 1 Testing: Participants will report to the lab after a 12 hour fast from food, dietary supplements, medications, and intake of all substances except water. Participants donate a fasting blood sample of approximately four teaspoons (~20 milliliters) of venous blood and then consume the assigned supplement along with a standardized breakfast. Blood samples will be taken 2, 4, and 6 hours following ingestion of the meal and supplement. Samples will be processed and stored at -20◦C until shipment. Washout Period. Participants will observe at least a 7-day washout period. Experiment 2 Testing: Participants will report to the lab in a fasted state and repeat the experiment while consuming the next randomly assigned treatment. Washout Period. Participants will observe at least a 7-day washout period. Experiment 3 Testing: Participants will report to the lab in a fasted state and repeat the experiment while consuming the final randomly assigned treatment. Block randomization method is used to assign to treatments: Treatment 1 – Food Based Multivitamin (mykind Organic Women’s/Men’s Multi) Treatment 2 – Non-Liposomal Universal Multivitamin Treatment 3 – Nutraceutical Liposomal Multivitamin |
| Intervention type | Supplement |
| Primary outcome measure | Blood samples will be taken 2, 4, and 6 hours following ingestion of the meal and supplement: 1. Area under the concentration vs. time curve (AUC) 2. Maximum observed concentration (Cmax) 3. Time of maximum observed concentration (Tmax) for each nutrient examined: Vitamins D2/D3, A, E, C, B12, and B9 (Folic Acid), magnesium and iron |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 04/01/2022 |
| Overall study end date | 30/01/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 25 |
| Participant inclusion criteria | 1. Age 18 to 65 years at time of consent; 2. Ability to comply with study procedures; and, 3. Availability to complete study based on durations of individual visits and scheduling requirements. |
| Participant exclusion criteria | 1. Presence of a disease or medical condition that could reasonably influence study outcomes or make participation inadvisable; 2. Use of medication that could reasonably influence study outcomes or make participation inadvisable; 3. Inability to abstain from medication, supplement, or substance use during the overnight fast and duration of the study visit; 4. Anticipated inability to provide blood samples (e.g., known difficulty providing blood samples); and/or 5. Currently pregnant or breastfeeding, based on self-report. |
| Recruitment start date | 05/01/2022 |
| Recruitment end date | 12/01/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
College Station
77843
United States of America
Sponsor information
Industry
222 S Main St, 16th Floor
Salt Lake City
84101
United States of America
| Phone | +1 4356556000 |
|---|---|
| mwillis@betterbeing.com | |
| Website | https://www.betterbeing.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planning on publishing in Nutrients |
| IPD sharing plan | Data and statistical analyses are available upon request on a case-by-case basis for non-commercial scientific inquiry and/or educational use if IRB restrictions and research agreement terms are not violated. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/07/2023 | 17/11/2023 | Yes | No |
Editorial Notes
17/11/2023: Publication reference added.
03/10/2022: Trial's existence confirmed by Texas A&M University
