Multivitamin and Mineral Supplementation and Healthy Aging

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorUniversity of California, San Diego

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • MVM Core Blend

    Dietary supplement

    Consists 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 supplement

    Pills, 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 supplement

    Pill contains no vitamins or minerals. 1 pill will be taken daily, 7 days/week, for 12 weeks

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: MVM Core BlendExperimental treatment 1 intervention
Group B: MVM Gold BlendExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of study at 14 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to end of study period at 14 weeks
2

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.

Time frame
Measures are taken from baseline to end of study at 14 weeks
3

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.

Time frame
Measurements are taken from baseline to the end of the study at week 14

Other outcomes

1

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.

Time frame
From enrollment to the end of study at 14 weeks
2

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.

Time frame
From enrollment to the end of treatment at 14 weeks.
3

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.

Time frame
From enrollment to the end of study period at 14 weeks.
4

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).

Time frame
From enrollment until 2 weeks and again in weeks 13 and 14.

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