NCT05651620进行中（未招募）不适用
Legacy Effects of CALERIE™, a 2-year Calorie Restriction Intervention, on Hallmarks of Healthspan and Aging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- Biological age - Klemera-Doubal Method
研究概览
简要总结
The purpose of the CALERIE Legacy Study is to follow up on the health and wellness of participants from phase 2 of the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trial, which was conducted from 2007 to 2011.
详细描述
The CALERIE Legacy Study is an observational follow-up study of participants from phase 2 the CALERIE trial, the first randomized controlled trial of calorie restriction (CR) in humans without obesity. The overarching goal of the CALERIE Legacy Study is to examine whether two years of CR results in sustained improvements in the biological, phenotypic, and functional hallmarks of human aging 10 to 15 years after the structured intervention. Participants will complete clinical assessments, dietary recalls, and questionnaires, and laboratory evaluations will be performed on blood and urine samples. The study also includes an optional biospecimen banking component.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 33 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in the CALERIE trial and started their allocated group (CR intervention or ad libitum control condition)
- •Willing and able to attend one of the clinical sites for an in-person visit and provide informed consent
排除标准
- •Pregnant women
- •Women less than 12 months postpartum
- •Documented note from the CALERIE trial indicating that the subject should not be contacted or requested not to be contacted for future research
- •Diagnosed active cancer or terminal illness
结局指标
主要结局
Biological age - Klemera-Doubal Method
时间窗: 10-15 years post CALERIE trial
Biological age will be quantified by the Klemera-Doubal Method (KDM), an algorithm-based measure. Biological age is expressed in years.
Healthspan
时间窗: 10-15 years post CALERIE trial
Healthspan will be assessed by sex-specific metabolic syndrome score (MSS). MSS was developed using mean blood pressure (MBP; = \[2 × diastolic blood pressure + systolic blood pressure\]/3), high density lipoprotein cholesterol (HDL), triglycerides (TG), waist circumference (WC), and fasting blood glucose (FBG): Women: MSS = \[45-HDL\]/SDHDLW+ \[TG-150\]/SDTG + \[WC-88\]/SDWCW + \[FBG-100\]/SDFBG + \[mean BP-100\]/SDMBP Men: MSS = \[40-HDL\]/SDHDLW+ \[TG-150\]/SDTG + \[WC-102\]/SDWCW + \[FBG-100\]/SDFBG + \[mean BP-100\]/SDMBP This score does not have a unit.
次要结局
- Height(10-15 years post CALERIE trial)
- Weight(10-15 years post CALERIE trial)
- Waist circumference(10-15 years post CALERIE trial)
- Hip circumference(10-15 years post CALERIE trial)
- Body mass index (BMI)(10-15 years post CALERIE trial)
- Blood pressure(10-15 years post CALERIE trial)
- Pulse rate at rest(10-15 years post CALERIE trial)
- Respiration rate at rest(10-15 years post CALERIE trial)
- Fat-free mass(10-15 years post CALERIE trial)
- Fat mass(10-15 years post CALERIE trial)
- Bone mineral content(10-15 years post CALERIE trial)
- Resting metabolic rate (RMR)(10-15 years post CALERIE trial)
- Respiratory quotient (RQ)(10-15 years post CALERIE trial)
- Maximal aerobic capacity (V̇O2max)(10-15 years post CALERIE trial)
- Interleukin-6 (IL-6)(10-15 years post CALERIE trial)
- Insulin - TAME panel(10-15 years post CALERIE trial)
- Insulin - 0 min (OGTT)(10-15 years post CALERIE trial)
- Insulin - 30 min (OGTT)(10-15 years post CALERIE trial)
- Insulin - 60 min (OGTT)(10-15 years post CALERIE trial)
- Insulin - 90 min (OGTT)(10-15 years post CALERIE trial)
- Insulin - 120 min (OGTT)(10-15 years post CALERIE trial)
- Insulin-like growth factor 1 (IGF-1)(10-15 years post CALERIE trial)
- Hemoglobin A1c (HbA1c)(10-15 years post CALERIE trial)
- Tumor necrosis factor α receptor II (TNFRII)(10-15 years post CALERIE trial)
- High-sensitivity C-reactive protein (hsCRP)(10-15 years post CALERIE trial)
- Growth/differentiation factor 15 (GDF15)(10-15 years post CALERIE trial)
- Cystatin C(10-15 years post CALERIE trial)
- N-terminal B-type natriuretic peptide (NT-proBNP)(10-15 years post CALERIE trial)
- Senescence-associated secretory phenotype (SASP) proteins(10-15 years post CALERIE trial)
- Urinary Isoprostanes - iPF(2α)-III(10-15 years post CALERIE trial)
- Urinary Isoprostanes - 2,3-dinor-iPF(2α)-III(10-15 years post CALERIE trial)
- Urinary Isoprostanes - iPF(2α)-VI(10-15 years post CALERIE trial)
- Urinary Isoprostanes - 8,12-iso-iPF(2α)-VI(10-15 years post CALERIE trial)
- Creatinine(10-15 years post CALERIE trial)
- Dehydroepiandrosterone (DHEA)(10-15 years post CALERIE trial)
- Interleukin 1 beta (IL-1b)(10-15 years post CALERIE trial)
- Interleukin 8 (IL-8)(10-15 years post CALERIE trial)
- Tumor necrosis factor α (TNF-α)(10-15 years post CALERIE trial)
- Insulin-like growth factor-binding protein 1 (IGFBP-1)(10-15 years post CALERIE trial)
- Transforming growth factor beta 1 (TGFB1)(10-15 years post CALERIE trial)
- Insulin-like growth factor-binding protein 3 (IGFBP-3)(10-15 years post CALERIE trial)
- Platelet-derived growth factor-AB (PDGF-AB)(10-15 years post CALERIE trial)
- Intercellular Adhesion Molecule 1 (ICAM-1)(10-15 years post CALERIE trial)
- Growth hormone(10-15 years post CALERIE trial)
- Monocyte Chemoattractant Protein 1 (MCP1)(10-15 years post CALERIE trial)
- Leptin(10-15 years post CALERIE trial)
- Total adiponectin(10-15 years post CALERIE trial)
- High molecular weight adiponectin(10-15 years post CALERIE trial)
- Muscle strength - Knee extension (60°)(10-15 years post CALERIE trial)
- Muscle strength - Knee extension (180°)(10-15 years post CALERIE trial)
- Muscle strength - Knee flexion (60°)(10-15 years post CALERIE trial)
- Muscle strength - Knee flexion (180°)(10-15 years post CALERIE trial)
- Handgrip Strength(10-15 years post CALERIE trial)
- Physical functioning(10-15 years post CALERIE trial)
- Cognition(10-15 years post CALERIE trial)
- Dietary intake- calories(10-15 years post CALERIE trial)
- Dietary intake - carbohydrates(10-15 years post CALERIE trial)
- Dietary intake - proteins(10-15 years post CALERIE trial)
- Health-related quality of life(10-15 years post CALERIE trial)
- Depression status(10-15 years post CALERIE trial)
- Mood(10-15 years post CALERIE trial)
- Sleep(10-15 years post CALERIE trial)
- Sexual function(10-15 years post CALERIE trial)
- Food cravings(10-15 years post CALERIE trial)
- Dietary restraint, disinhibition, and hunger(10-15 years post CALERIE trial)
- Disordered eating(10-15 years post CALERIE trial)
- Body shape perceptions(10-15 years post CALERIE trial)
- Physical activity(10-15 years post CALERIE trial)
- Resilience(10-15 years post CALERIE trial)
- Total cholesterol(10-15 years post CALERIE trial)
- High-density lipoprotein cholesterol (HDL-C)(10-15 years post CALERIE trial)
- Triglycerides(10-15 years post CALERIE trial)
- Low-density lipoprotein cholesterol (LDL-C)(10-15 years post CALERIE trial)
- Glucose - 0 min (OGTT)(10-15 years post CALERIE trial)
- Glucose - 30 min (OGTT)(10-15 years post CALERIE trial)
- Glucose - 60 min (OGTT)(10-15 years post CALERIE trial)
- Glucose - 90 min (OGTT)(10-15 years post CALERIE trial)
- Glucose - 120 min (OGTT)(10-15 years post CALERIE trial)
- Insulin resistance(10-15 years post CALERIE trial)
- Beta-cell function(10-15 years post CALERIE trial)
- Triiodothyronine (T3)(10-15 years post CALERIE trial)
- Thyroxine (T4)(10-15 years post CALERIE trial)
- Thyroid stimulating hormone (TSH)(10-15 years post CALERIE trial)
- Alkaline phosphatase (ALKP)(10-15 years post CALERIE trial)
- Alanine transaminase (ALT)(10-15 years post CALERIE trial)
- Aspartate aminotransferase (AST)(10-15 years post CALERIE trial)
- Albumin(10-15 years post CALERIE trial)
- Blood Urea Nitrogen (BUN)(10-15 years post CALERIE trial)
- Total Proteins(10-15 years post CALERIE trial)
- Bilirubin(10-15 years post CALERIE trial)
- Creatine Phosphokinase (CPK)(10-15 years post CALERIE trial)
- Lactate Dehydrogenase (LDH)(10-15 years post CALERIE trial)
- Globulin(10-15 years post CALERIE trial)
- Albumin/Globulin (A/G) ratio(10-15 years post CALERIE trial)
- Uric Acid(10-15 years post CALERIE trial)
- Calcium (Ca)(10-15 years post CALERIE trial)
- Phosphorus (P)(10-15 years post CALERIE trial)
- Magnesium (Mg)(10-15 years post CALERIE trial)
- Sodium (Na+)(10-15 years post CALERIE trial)
- Potassium (K+)(10-15 years post CALERIE trial)
- Chloride (Cl-)(10-15 years post CALERIE trial)
- Apoprotein A1(10-15 years post CALERIE trial)
- Apoprotein B(10-15 years post CALERIE trial)
- Biological age - Homeostatic Dysregulation(10-15 years post CALERIE trial)
- Biological age - Levine Phenotypic Age(10-15 years post CALERIE trial)
研究者
研究点 (6)
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