Effects of Sex-Speciffic Compound Food Supplements on Changes in Biomarkers and Epigenetic Changes Associated With Longevity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Albumin
研究概览
简要总结
The use of food supplements with the aim of increasing longevity in the general population is rapidly increasing, while high-quality clinical evidence on the efficacy of comprehensive formulations and their impact on biomarkers of aging is lacking. The investigators will perform a double-blind, placebo-controlled, randomized clinical trial of a selected sex-specific dietary supplement in relation to longevity in a selected population of healthy adults of both sexes between the ages of 50 and 70.
The main questions the study answers are:
Does the 6-month use of the longevity supplement impacts the 6-months change in different markers for measuring biological age compared to placebo?
The study will involve 60 subjects, of whom 30 will consume the sex-specific longevity food supplements and 30 will consume a placebo.
The study will last 6 months. The participants will visit the Faculty four times: at the beginning of the study (background measurement), after one, three and six months of consuming the dietary supplement or placebo.
At each visit, the participants will undergo anthropometric measurements, blood pressure measurements, and blood samples will be taken to determine baseline haematocrite, albumin, creatinine, alcaline phosphatase, lipid profile, glucose concentration, inflammatory parameters, antioxidant potential, inflammatory markers, liver enzymes, and expression of genes for autophagy and oxidative stress. The participants will also complete 3-day food diaries and questionnaires on general health, physical activity, and quality of sleep and life.
On baseline and final (six months) measurements resting metabolic rate, DXA body composition measurements will be performed and saliva samples will be obtained for DNA methilation determination.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 22 kg/m2 and 30 kg/m2
- •Postmenopausal women (at least 12 months without menstruation)
- •Healthy individuals, without risk of chronic non-communicable diseases
- •Signed written informed consent
排除标准
- •Acute and chronic diseases (cardiovascular diseases, diabetes, neurodegenerative diseases, gastrointestinal diseases)
- •Patients with serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases
- •BMI less than 22 kg/m2 and greater than 30 kg/m2
- •Celiac disease or gluten intolerance
- •Presence of implants, devices or other foreign materials in the measurement area
- •Atypical sleep patterns
- •Use of dietary supplements and medications
- •Extreme physical activity
- •Excessive alcohol consumption (more than one drink per day for women, more than two drinks per day for men)
研究组 & 干预措施
Female longevity food supplement
6-month daily consumption of 2 capsules of female food supplement in the morning.
干预措施: compound food supplements - female specific (Dietary Supplement)
Female placebo
6-month daily consumption of 2 capsules of maltodextrin in the morning.
干预措施: Placebo (Dietary Supplement)
Male longevity food supplement
6-month daily consumption of 2 capsules of male food supplement in the morning.
干预措施: compound food supplements - male specific (Dietary Supplement)
Male placebo
6-month daily consumption of 2 capsules of maltodextrin in the morning.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Albumin
时间窗: From enrolment to the end of last measurement at 6 months.
Albumin levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Creatinine
时间窗: From enrolment to the end of last measurement at 6 months.
Creatinine levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Glucose
时间窗: From enrolment to the end of last measurement at 6 months.
Glucose levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
CRP
时间窗: From enrolment to the end of last measurement at 6 months.
CRP levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Lymphocyte percent
时间窗: From enrolment to the end of last measurement at 6 months.
Lymphocyte percent will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Mean cell volume
时间窗: From enrolment to the end of last measurement at 6 months.
Mean cell volume will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Red cell distribution width
时间窗: From enrolment to the end of last measurement at 6 months.
Red cell distribution width will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Alcaline phosphatase
时间窗: From enrolment to the end of last measurement at 6 months.
Alcaline phosphatase will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
White blood cell count
时间窗: From enrolment to the end of last measurement at 6 months.
White blood cell count will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
PhenoAge
时间窗: From enrolment to the end of last measurement at 6 months.
PhenoAge will be calculated from albumin, creatinine, glucose, lymphocyte percent, mean cell volume, red cell distribution width, alcaline phosphatase, white blood cell count and cronological age at baseline, after 1, 3 and 6 months of daily dietary supplements use (according to Ruan et al, 2023).
DNA methylation
时间窗: From enrolment to the end of last measurement at 6 months.
DNA methylation will be measured from saliva at baseline and 6 months of daily dietary supplements use.
Horvath epigenetic age
时间窗: From enrolment to the end of last measurement at 6 months.
Horvath epigenetic age will be determined from saliva DNA methylation data (according to Horvath \& Raj, 2018) at baseline and 6 months of daily dietary supplements use..
次要结局
- Total cholesterol(From enrolment to the end of last measurement at 6 months.)
- LDL cholestorol(From enrolment to the end of last measurement at 6 months.)
- HDL cholesterol(From enrolment to the end of last measurement at 6 months.)
- Triacylglycerols(From enrolment to the end of last measurement at 6 months.)
- Antioxidant potential(From enrolment to the end of last measurement at 6 months.)
- Aspartate aminotransferase (AST)(From enrolment to the end of last measurement at 6 months.)
- Alanine aminotransferase (ALT)(From enrolment to the end of last measurement at 6 months.)
- Interleukine-6 (IL-6)(From enrolment to the end of last measurement at 6 months.)
- Tumor necrosis factor alpha (TNF-alpha)(From enrolment to the end of last measurement at 6 months.)
- NAD+/NADH(From enrolment to the end of last measurement at 6 months.)
- mTOR gene expression(From enrolment to the end of last measurement at 6 months.)
- Sleep quality(From enrolment to the end of last measurement at 6 months.)
- World Health Organization-FIve Well-Being Index(From enrolment to the end of last measurement at 6 months.)
- BMAL1 gene expression(From enrolment to the end of last measurement at 6 months.)
- ATG1 gene expression(From enrolment to the end of last measurement at 6 months.)
- SD1 gene expression(From enrolment to the end of last measurement at 6 months.)
- SIRT1 gene expression(From enrolment to the end of last measurement at 6 months.)
- Glutation reductase gene expression(From enrolment to the end of last measurement at 6 months.)
研究者
Nina Mohorko
Associate Professor
University of Primorska