Randomized, Double-Blind, Crossover Study to Assess the Effects of a Spermidine Supplement on Metabolomics in Older Men
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Evaluation of the safety and effects of a high purity Spermidine supplement in healthy older men.
研究概览
简要总结
Spermidine is naturally present in cells, organs, circulating cardiovascular system, and as part of our normal dietary intake. Studies suggest Spermidine is involved in antioxidation, autophagy, apoptosis, and immune regulation. Spermidine is typically present in foods of plant origin, such as natto, beans, fruits, vegetables, cheese, potatoes, bread, and cereals. Adequate spermidine dietary intake is important, given evidence of declining spermidine levels with age in humans and other species, and the evidence for positive effects of spermidine supplementation on age related biology.
To date, human research studies utilised extracts containing low levels of spermidine (< 10%) and multiple other constituents, but this study will use pure spermidine to explore relevant mechanisms of action, biological effects, and identify potential biomarkers of positive biological effects.
详细描述
This is a placebo controlled, double blind, randomised, within subject controlled study of supplementation with oral spermidine or placebo each for up to four weeks. The primary objective of this exploratory study is to examine the safety and biological effects of this pure full-dose spermidine supplement on metabolomics, inflammatory and metabolic markers, and transcriptomics.
Study subjects are generally healthy males aged 50-70 After screening, subjects will enter a two week run-in (stabilisation) phase and then be randomised to blinded active or placebo for the first one week supplementation period. After a washout period, subjects will receive either blinded placebo or active for a second supplementation period of up to four weeks. The full study will require six visits by each study subject to the study site over a period of nine weeks, for blood and urine samples, and dietary intake assessments.
Subjects are required to maintain a normal consistent dietary intake during the study and abstain from alcohol in the 24 hours before study visits.
Assays include routine haematology and chemistry, CRP (C reactive protein), lipid screen, serum and urine metabolomics and polyamines, lipidomics, transcriptomics, and autophagy assays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian men, 50-70 years of age
- •Non-user or former users (cessation ≥6 months) of nicotine products (e.g., cigarettes, chewing tobacco) during the study period.
- •Non-user or former users (cessation ≥6 months) of any marijuana or hemp products and no plans to use marijuana or hemp products during the study period
- •Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
- •No health conditions that would prevent the subject from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history, physical examination, and routine laboratory test results.
- •Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
排除标准
- •Abnormal laboratory test results of clinical significance
- •Clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product
- •Type I or Type II diabetes mellitus.
- •Uncontrolled pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, endocrine, hematologic, immunologic, or neurologic disease.
- •Had a positive SARS-CoV2 (COVID) test and experienced symptoms for > 2 months (i.e. long COVID)
- •Has a condition the Clinical Investigator believes would interfere with ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk
结局指标
主要结局
Evaluation of the safety and effects of a high purity Spermidine supplement in healthy older men.
时间窗: Baseline, and after one, three, four and seven weeks at each study visit. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.
Subjects will be evaluated using clinical and laboratory safety testing at baseline and each subsequent study visit. Each participant will be tracked longitudinally during the study using clinical and laboratory safety parameters
次要结局
- Polyamine levels in urine and blood(Baseline, one week, and one month)
- Serum lipidomics(baseline, one week, and one month)
- CRP marker of inflammatory activity(Baseline, and one month)
- Evaluation of molecular biology and bioeffect signalling using untargeted and targeted Metabolomics(Baseline, one week, and one month. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.)
- Urinary untargeted and targeted metabolomics. Evaluation of molecular biology and bioeffect signalling and biomarker assessment(Baseline, one week, and one month. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.)
- Autophagy assay(Baseline and one week)