The Impact of a Phytochemical Supplement on "Metabolic Aging" in Older Overweight Adults Relative to Young Lean Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- mitochondrial function
研究概览
简要总结
Aging is a complex and inevitable biological process that is associated with numerous chronic health conditions and the development and progression of diseases. It is manifested partly by a progressive decline in fitness and an increase in death. The key to healthy aging is a healthy lifestyle, including eating a variety of healthy foods and frequently participating in physical activities. Supplements made from widely consumed plant products have the potential for promoting healthy aging. However, more human data is required to substantiate this potential. Thus, the purpose of this study is to determine examining whether older adults taking a fruit/vegetable supplement for 6 weeks will have biochemical values of stool, blood, and urine similar to those of younger adults. The fruit/vegetable supplement contains a variety of vitamins and minerals and other nutrients that have been known to be beneficial to human health and many Americans may consume inadequate amounts in their daily diet. In order for us to understand how these nutrients may benefit health, we are interested in determining whether they can modify biochemical values of blood that occur in the body after taking the supplement for 6 weeks. We aim to have 40 older subjects and 20 younger subjects complete the trial. The enrolled subjects will consume prepackaged study meals for approximately 8 weeks and provide blood samples. The study meals will comprise foods most Americans eat every day. The older subjects, but not younger subjects, will take the assigned supplement. The younger subjects will consume the study meals for 2 weeks and provide one blood sample during the study.
详细描述
Advanced age is associated with reduced mitochondrial capacity and altered metabolomic signatures relative to those at younger ages. We hypothesize that supplemental fruit and vegetable phytochemicals will slow or reverse signs of metabolic aging by enhancing mitochondrial capacity in older, overweight/obese adults as well as shift their metabolomic signature toward those of younger, leaner adults. To test this hypothesis, we will pursue the following specific aims in a controlled feeding trial to diminish the confounding effect of concurrent and confounding dietary factors.
Specific Aim 1: To determine the extent to which supplemental fruit and vegetable concentrates will shift the mitochondrial capacity of peripheral blood mononuclear cells in older, overweight older adults toward that of young, lean adults.
Specific Aim 2: To determine the extent to which supplemental fruit and vegetable concentrates will shift the plasma metabolomic signature of older, overweight adults toward that of young, lean adults.
The experimental design is a randomized, double-blind, placebo-controlled, parallel design, controlled feeding trial. This trial will enroll 40 older adults, as well as 20 younger adults to serve as a reference, to complete the study. They will be generally healthy. The older adults will be ≥55 y and have BMI >27.0 and <35 kg/m2, and the younger adults will be 18-30 y and have BMI >18.5 and <27 kg/m2. The older subjects will be randomized to receive either placebo (PLA) or fruit/vegetable supplement (FVS) for 6 weeks after a 2-wk run-in period. The younger adults serving as the reference group for the older subjects will only participate in the run-in period and will not receive any dietary supplements. During the whole study, including the run-in period, all subjects will consume provided meals. The total duration of the trial will be ~10 weeks for the older subjects, including screening, 2-wk run-in, and 6 wk of intervention, as well as ~4 weeks for the younger subjects including screening and 2-wk run-in. In addition to consuming the provided meals for 6 weeks, the older volunteers will take an assigned supplement daily. Blood samples of the older volunteers will be collected at the end of the run-in and the end of the 6-wk intervention. These same samples will only be collected from the younger volunteers at the end of the run-in period.
Older subjects will be randomly assigned to receive one of the supplements (PLA vs. FVS) after their eligibility is confirmed. A randomization scheme will be prepared by a biostatistician using a standardized computer program for two treatment groups using a parallel design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
capsules for 2 supplement have the same color and shape
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Age, ≥55 y old
- •BMI, ≥27 and <35 kg/m2
- •Consume a typical American diet, <3 servings of combined fruits and vegetables daily
- •Waist:hip ratio >0.8 for women and >0.9 for men, and waist:height ratio ≥0.5
- •Willing to consume study meals for 8 wk
- •Do not have allergic reaction to plant foods
- •Willing to take the assigned supplement for 6 wk
排除标准
- •Unusual dietary pattern, including vegan/vegetarian
- •Cigarette smoking and/or nicotine replacement use in the last 6 months
- •Intend to be pregnant, pregnancy, and breastfeeding
- •Use of medications known to change lipid metabolism
- •Steroid use, except nasal and non-prescription topical treatments
- •Active treatment for cancer of any type >1 y, except non-melanoma skin cancer
- •Have an immunodeficiency condition
- •Use of immunosuppressive medications within the last 6 months
- •Weekly alcoholic intake >14 drinks (168 oz beer, 56 oz wine, 14 oz hard liquor)
- •Drugs known to influence fecal microbiota: Regular use of fiber supplements such as Metamucil, probiotics, prebiotics, laxatives, stool softeners, H2 blockers, proton pump inhibitors (PPI) or antacids.
- •Antibiotic use within 3 months prior to or during study participation
- •Colonoscopy or colonoscopy prep within 3 months prior to or during study
- •Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
- •History of a bilateral mastectomy with nodal dissection
- •Consume ≥3 servings of fruits and vegetables daily one average
- •Gastrointestinal diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease or inflammatory bowel disease which will be found based on the self-report during the screening visit
- •Diabetes and/or use of diabetes medications
- •Unstable thyroid disease or adjustment of thyroid medication in past 6 months
- •Abnormal values of standard blood biochemistries that interfere with study outcomes based on study physician's discretion
- •Infection or immunization within 30 days prior to study admission
- •Use anticoagulants, such as heparin, warfarin (coumadin), or Plavix in past 6 months
- •On or planning to be on a weight loss regimen
- •Gain or loss of ≥5% body weight in the last 6 months
- •Inability to refrain from ASA/NSAID/Tylenol use x 720 prior to study blood draws
- •Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) prebiotics, probiotics or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements 30 days prior to enrollment and throughout the entire study may be considered eligible
结局指标
主要结局
mitochondrial function
时间窗: at end of 6-week intervention
Targeted central carbon metabolomic in peripheral blood mononuclear cells
次要结局
- metabolomics(at end of 6-week intervention)
研究者
Oliver Chen
Director of Nutrition Science and Biostatistics
Biofortis, Merieux NutriSciences