About this trial
The goal of this study is to determine the impact of MVM supplementation on clinical and biochemical markers associated with healthy aging, with a particular focus on mitochondrial function and metabolism. Specifically, changes in mitochondrial respiration using isolated blood cells will be measured. This method has been used to compare with various other age-related markers of health such as physical function, gait speed, and resting metabolic rate. It is hypothesize that MVM supplementation will impact the function of blood cells. MVM supplementation impacts other markers of health, including serum nutrient levels, metabolomic profiles, physical function, and skeletal muscle composition and quality will be explored. These comprehensive assessments will provide insights into the potential benefits of MVM supplementation for healthy aging and address critical gaps in our understanding of its immediate effects. Further, this study will aid in the understanding of how multivitamin supplements can support heathy aging in mid-life adults, a key time to start including wellness programs in people's lives.
The study cohort will consist of 150 sedentary men and women aged 40-60-years of age. A double-blind, three-arm, placebo-controlled randomized clinical trial will be conducted. Participants will receive a daily oral tablet containing one of two possible formulations of vitamins and minerals or a placebo. The three groups will be MVM "GOLD" blend formula, the US Restage MVM "US CORE", and the placebo group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
IPAQ-SF categorical score of low or moderate physical activity (indicating sedentary lifestyle).
Stated willingness to comply with all study procedures and availability for the duration of the study
Between 40-60 years of age
BMI ≥18.5 and ≤32 kg/m2
Disqualifiers
Is pregnant or nursing.
Current smoker.
Diabetes (FPG > 180 mg/dL or A1c>8)
Heart or cardiovascular condition, including coronary artery disease, congestive heart failure, diagnosed abnormality of heart rhythm, atrial fibrillation and/or a history of myocardial infarction
Trial design
Parallel
Treatments tested in this trial
MVM Core Blend
Dietary supplementConsists of a pill containing a 22-ingredient blend of vitamins and minerals 1 pill will be taken daily, 7 days/week for 12 weeks
MVM Gold Blend
Dietary supplementPills, participants will take contain a 17-ingredient blend of vitamins and minerals. Instructions: 1 pill each day, 7 days/week for 12 weeks
Placebo
Dietary supplementPill contains no vitamins or minerals. 1 pill will be taken daily, 7 days/week, for 12 weeks
Treatment groups
Trial outcomes
Primary outcomes
PBMC Respiratory Capacity by Oxymetry
Multivitamin and mineral supplementation may have an impact on blood cell bioenergetics. The high-resolution Oroboros Oxygraph 2k as well as high throughput Seahorse will be used to measure maximal oxidative phosphorylation (Max OXPHOS) in freshly prepared PBMCs. Max OXPHOS is the highest measured rate of mitochondrial ATP production and is measured in picomols of oxygen per time weight, or pmol/s\*mg. This measurement will be taken at baseline and after completion of the study supplementation.
Secondary outcomes
Serum concentrations of dietary Vitamins B6 and E
Dietary nutrients will be measured from two study time points: baseline and study completion. Serum nutrient levels to be measured are Vitamins B6 and E are measured by automated analyzer and are reported in mg/L.
Serum concentrations of Vitamin C and Beta-Carotene
Dietary nutrients will be measured from two study time points: baseline and study completion. Serum nutrient levels to be measured are Vitamins c and Beta carotene and are measured by automated analyzer. These are reported in mg/Dl.
Serum concentrations of Vitamins D and B12
Dietary nutrients will be measured from two study time points: baseline and study completion. Serum nutrient levels to be measured are Vitamins D and B12 and are measured by automated analyzer. These are reported in pg/mL.
Other outcomes
Measures of Grip Strength by hand-held dynamometer
Strength will be measured by hand grip in both hands using an adjustable grip strength dynamometer (BL5001 Hydraulic Hand Dynamometer). Participants will have a chance to familiarize themselves with the measurement by making a submaximal effort on both hands to feel how the instrument will react. For the assessment, the participant will stand and hold the dynamometer in their hand with their arm down at their side. The participant will be instructed to take a deep breath in and squeeze as hard as possible as they exhale. The measurement will be repeated twice on each hand, alternating between each side, and the highest score for each hand will be recorded to the nearest kg.
Changes in self-reported measures of Diet Quality
Computer adapted testing measure, Diet History Questionnaire (DHQ III), a general population dietary survey that queries food intake frequency and portion size. It is scored numerically from 0 to 100, with higher scores indicating better diet quality.
Cardiovascular Function
Submaximal Graded Exercise Test (GXT) on a treadmill will be conducted at EPARC under the supervision of a trained exercise physiologist. Participants will complete a walking protocol at a self-selected speed, with the treadmill incline increasing every two minutes to progressively increase cardiovascular demand. The test will continue until the participant reaches 85% of their age-predicted maximal heart rate (calculated as 220 bpm - age) or experiences volitional fatigue, whichever occurs first.
Physical Activity
Objective assessments of physical activity will be measured using the ActiGraph accelerometer , a lightweight instrument that is worn on the hip attached to a belt around the waist. Instructions will be provided, and a brief self-report wear time log for participants to note periods that the device was taken off. Participants will be asked to wear the ActiGraph for seven days and will be prompted twice via telephone during the monitoring period (wear days 2 and 5) to assist with compliance. Upon return, we will immediately download data outcome variables which include (i) mean minutes per day of sedentary time, (ii) mean minutes per day of light intensity physical activity, and (iii) minutes per week of moderate-to-vigorous intensity physical activity (MVPA).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
HALEON
Collaborator