ACTRN12623000260628招募中未知
Effect of Nutritional INterventions on Autophagy in healthy adults (The NINA Study)
Dr Timothy Sargeant0 个研究点目标入组 61 人开始时间: 2023年3月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1, Aged between 20 and 50 years of age
- •2. BMI between 18.5 and 29.9 kg/m2
排除标准
- •1. Diagnosis or evidence of neurodegenerative disorder such as Alzheimer’s disease.
- •2. Any co-morbidities that are likely to change the activity of the lysosomal system, such as cancer, diabetes, cardiovascular disease/conditions (stroke, heart attack, high blood pressure), renal or liver disease, hemoglobin disorder or anaemia, gastrointestinal surgery or disease, major psychiatric disorders (schizophrenia, addiction, eating disorders, unstable major depressive disorder), neurological disorders, and/or any other condition deemed likely to affect the results by the study principal investigator.
- •3. Taking any medications that, in the opinion of the investigator, might change autophagic activity; including, but not restricted to, chronic medications or supplements that change appetite, body composition or metabolism (e.g. medications used to lower blood glucose, antidiabetic medications), anti-inflammatory medications, medications used in the treatment of cancer or cardiovascular disorders.
- •4. Female participants taking hormonal contraceptive will not be excluded from the study. It is preferable but not essential that women who have a menstrual cycle attend the M1 baseline study appointment between day 1 and day 10 of their menstrual cycle. Date of first day of menstrual cycle will be documented as well as cycle length in days at both Screening Visit and Metabolic Visits.
- •5. Anyone who is not weight stable (lost or gained > 5% body weight in the last 3 months).
- •6. Current alcohol abuse (>14 standard drinks/week) and/or substance use disorder.
- •7. Current smoker.
- •9. Lactose intolerance.
- •10. Pregnant or breastfeeding women or women planning a pregnancy.
- •11. Women who have been through menopause or peri-menopausal.
- •12. Self-reported dietary practice or restriction that may affect autophagy (including calorie restriction, intermittent fasting and ketogenic diets).
- •13. Self-reported high consumption of protein or supplements.
- •14. Anyone who has an eating disorder, food allergies or practices that are likely to interfere with compliance (eg. coeliac, gluten intolerance, and nut allergies).
- •15. Anyone who is unable to comprehend the study protocol (i.e. due to English language or cognitive difficulties).
- •16. Anyone with a pacemaker or other internal electronic medical devices.
研究者
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