The Impacts of Multivitamin and Mineral Supplementation on Cellular Metabolism and Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
As the global population of older adults continues to expand, it is imperative to identify accessible and evidence-based interventions to support healthy aging. Among the key biological hallmarks of aging, mitochondrial dysfunction is highly modifiable and especially responsive to lifestyle interventions such as diet and exercise. Importantly, our clinical studies demonstrate that mitochondrial bioenergetics plays a key role in the physical and cognitive abilities of older adults. Thus, identifying interventions that can improve mitochondrial bioenergetics is a promising avenue for the development of healthy aging interventions.
Multivitamin and mineral (MVM) dietary supplements have been used to support general health and nutritional status for years, particularly in older adults who are more susceptible to nutritional deficiencies due to factors such as reduced appetite, malabsorption, and polypharmacy. Observational studies consistently demonstrated that older adults exhibit higher rates of nutritional deficiencies, and that MVM supplementation may ameliorate these burdens. More recently, evidence suggests that MVM use may also confer functional health benefits; for example, the COSMOS-Mind trial demonstrated efficacy of MVM on global cognition, memory, and executive function in 2262 participants. Notably, most MVM studies are longitudinal and occur over the course of many years. A significant gap remains in understanding the acute effects of MVM supplementation on health and aging. Can rapid, measurable improvements in health be observed with MVM use? Moreover, what are the cellular mechanisms that can underlie the benefits of MVM use?
Description of Study Intervention: 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. Specific formulations of the three tablets are detailed in the 2025 Stability Provisional Expiry for Centrum Gold Blend Tablets (FN-2492-0001), Centrum US Restage Blend Tablets (FN-2493-0001, and Placebo of Centrum Gold Blend Tablets (FN-0436-0231) -
Assessments:
The baseline study visit will occur at least 2 weeks after, but no more than 4 weeks after, the initial screening visit (actigraph will be deployed at screening and will be worn for 2 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究者
Anthony Molina
Professor
University of California, San Diego
