Multivitamin and Mineral Supplementation and Healthy Aging

NCT07642869 | Recruiting

• 1 other identifier: 812601
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. We will also explore how MVM supplementation impacts other markers of health, including serum nutrient levels, metabolomic profiles, physical function, and skeletal muscle composition and quality. 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 our 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.

Conditions

Healthy Aging; Multivitamin and Mineral Supplementation

Keywords

Multivitamin and mineral supplements; Supplements; Cellular metabolism; healthy aging; mitochondria; Respirometry

Outcome Measures

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.

  From enrollment to the end of study at 14 weeks

Secondary Outcomes (3)

• Serum concentrations of dietary Vitamins B6 and E

  From enrollment to end of study period at 14 weeks

• Serum concentrations of Vitamin C and Beta-Carotene

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

• Serum concentrations of Vitamins D and B12

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

Other Outcomes (8)

• Measures of Grip Strength by hand-held dynamometer

  From enrollment to the end of study at 14 weeks

• Changes in self-reported measures of Diet Quality

  From enrollment to the end of treatment at 14 weeks.

• Cardiovascular Function

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

Study Arms (3)

MVM Core Blend

EXPERIMENTAL

This is a modification to currently marketed Centrum Adult in which select nutrients have been removed or lowered to provide a better consumer experience. This will be consumed once per day for the duration of the study.

Dietary Supplement: MVM Core Blend

MVM Gold Blend

EXPERIMENTAL

Because Centrum is a global multivitamin/multimineral brand, it has numerous product formulations for different regions/markets around the world. To better harmonize these formulations across key markets, a 'core' blend of vitamins and minerals has been designed at levels that can be leveraged across different markets - this is internally being referred to as the MVM "GOLD" Blend formula. This will be consumed once per day for the duration of the study.

Dietary Supplement: MVM Gold Blend

Placebo

PLACEBO COMPARATOR

The placebo is a pill of the same color, size, and density as the experimental pills. It contains no vitamins or minerals. It will be administered once a day as the experimental pills.

Dietary Supplement: Placebo

Interventions

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 Core Blend

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

MVM Gold Blend

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Weight stable for the prior 6 weeks

You may not qualify if:

• 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
• Cancer or history of cancer within the past 5 years
• Sensory or physical impairment that would prevent participation
• Parkinson's disease, multiple sclerosis or other neurological condition, including a previous stroke, that may be causing impaired muscle function or mobility
• Consistent use of any multivitamin and mineral supplement use, or any supplement that may interfere with measurements or biological outcomes (including but not limited to: NAD+ supplements, MitoQ)
• Individuals with drug interactions as determined by the study physician

Sponsors & Collaborators

• University of California, San Diego: lead
• HALEON: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

Related Publications (7)

• Gonzalez-Armenta JL, Bergstrom J, Lee J, Furdui CM, Nicklas BJ, Molina AJA. Serum factors mediate changes in mitochondrial bioenergetics associated with diet and exercise interventions. Geroscience. 2024 Feb;46(1):349-365. doi: 10.1007/s11357-023-00855-w. Epub 2023 Jun 27.

  PMID: 37368157 BACKGROUND

• Gonzalez-Armenta JL, Gao Z, Appt SE, Vitolins MZ, Michalson KT, Register TC, Shively CA, Molina AJA. Skeletal Muscle Mitochondrial Respiration Is Elevated in Female Cynomolgus Macaques Fed a Western Compared with a Mediterranean Diet. J Nutr. 2019 Sep 1;149(9):1493-1502. doi: 10.1093/jn/nxz092.

  PMID: 31112997 BACKGROUND

• Kramer PA, Coen PM, Cawthon PM, Distefano G, Cummings SR, Goodpaster BH, Hepple RT, Kritchevsky SB, Shankland EG, Marcinek DJ, Toledo FGS, Duchowny KA, Ramos SV, Harrison S, Newman AB, Molina AJA. Skeletal Muscle Energetics Explain the Sex Disparity in Mobility Impairment in the Study of Muscle, Mobility and Aging. J Gerontol A Biol Sci Med Sci. 2024 Apr 1;79(4):glad283. doi: 10.1093/gerona/glad283.

  PMID: 38150179 BACKGROUND

• Scandalis L, Kitzman DW, Nicklas BJ, Lyles M, Brubaker P, Nelson MB, Gordon M, Stone J, Bergstrom J, Neufer PD, Gnaiger E, Molina AJA. Skeletal Muscle Mitochondrial Respiration and Exercise Intolerance in Patients With Heart Failure With Preserved Ejection Fraction. JAMA Cardiol. 2023 Jun 1;8(6):575-584. doi: 10.1001/jamacardio.2023.0957.

  PMID: 37163294 BACKGROUND

• Mahapatra G, Gao Z, Bateman JR 3rd, Lockhart SN, Bergstrom J, DeWitt AR, Piloso JE, Kramer PA, Gonzalez-Armenta JL, Amick KA, Casanova R, Craft S, Molina AJA. Blood-based bioenergetic profiling reveals differences in mitochondrial function associated with cognitive performance and Alzheimer's disease. Alzheimers Dement. 2023 Apr;19(4):1466-1478. doi: 10.1002/alz.12731. Epub 2022 Jul 23.

  PMID: 35870133 BACKGROUND

• Tyrrell DJ, Bharadwaj MS, Van Horn CG, Kritchevsky SB, Nicklas BJ, Molina AJ. Respirometric Profiling of Muscle Mitochondria and Blood Cells Are Associated With Differences in Gait Speed Among Community-Dwelling Older Adults. J Gerontol A Biol Sci Med Sci. 2015 Nov;70(11):1394-9. doi: 10.1093/gerona/glu096. Epub 2014 Jul 16.

  PMID: 25030980 BACKGROUND

• Wallace TC, Frankenfeld CL, Frei B, Shah AV, Yu CR, van Klinken BJ, Adeleke M. Multivitamin/Multimineral Supplement Use is Associated with Increased Micronutrient Intakes and Biomarkers and Decreased Prevalence of Inadequacies and Deficiencies in Middle-Aged and Older Adults in the United States. J Nutr Gerontol Geriatr. 2019 Oct-Dec;38(4):307-328. doi: 10.1080/21551197.2019.1656135. Epub 2019 Sep 10.

  PMID: 31502930 BACKGROUND

Study Officials

• Anthony Molina, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Scandalis, PhD

CONTACT

18588226443; Lscandalis@health.ucsd.edu

David Wing, PhD

CONTACT

8585349317; dwing@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will involve a double-blind, three-arm, placebo controlled randomized clinical trial. The study cohort will consist of 150 (50 per arm) sedentary men and women aged 40-60 years old. Participants will receive a daily oral tablet containing one of two possible specific formulations of vitamins and minerals while the placebo group receives a tablet with a similar appearance and taste but lacking active ingredients. The baseline visit (V1, Week 0) will involve clinical measurements (blood draw, vitals, , DXA scan), measure of activity level, and dispensing of the supplement. An acute follow-up visit (V2, Week 2) will involve the same clinical measurements. The last treatment visit (V3, Week 12) is post-intervention. Over the entire study period, a weekly digital surveys of quality of life, mood, and sleep habits as well as a survey of adverse events will be deployed.

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: June 11, 2026
• Study Start: September 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)