ACTRN12623000159651已完成未知
Investigating the effect of Swisse's body activator product on mild to moderate fatigue symptoms in middle-aged adults
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 320
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
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Evidence of an electronically signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.
- •2.Aged between 40 and 65 years, both inclusive.
- •3.Self-reported mild-to-moderate symptoms of fatigue as measured by FAS score between 22 and 34 (Hendricks et al., 2018).
- •4.Self-reported absence of any chronic health conditions or co-morbidities, and absence of any medication relating to such conditions. With the exception of medically managed hypertension and associated medications, medically managed high cholesterol and associated medications and contraceptives.
- •5.Body mass index (BMI) lower than 35 kg/m2
- •6.Female subjects of child-bearing potential are eligible if:
- •currently using the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, vaginal ring, or injection) for at least 3 months prior to study inclusion and throughout the study OR
- •currently using a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap or spermicide) for at least 1 month prior to study inclusion and throughout the study OR
- •have no sexual intercourse and agreeing not to have any throughout the study OR
- •are surgically sterile (oophorectomy, hysterectomy or tubal ligation). OR
- •are having non-childbearing potential sex - e.g., vasectomised partner, same-sex relationship OR
- •7.Individuals who agree to continue their usual” exercise routine during the study period.
排除标准
- •1.Individuals with significant past medical and psychiatric history and ongoing chronic conditions, including mental health disorder (e.g., depression, anxiety-related disorder, eating disorder, psychosis/schizophrenia) or medical illness including diabetes, autoimmune diseases, cardiovascular disease, hypertension, chronic fatigue syndrome, or asthma (medically managed hypertension and medically managed high cholesterol are acceptable).
- •2.Individuals who are pregnant and/or lactating, or who are planning to become pregnant during the study or four (4) weeks after the study
- •3.Individuals who have taken any of the following supplements in the last 14 days (e.g., (multi)vitamins, Vitamin B, Magnesium or any other supplements (vitamins/minerals or herbals) that target physical energy and/or mental stamina.
- •4.Individuals who performed/followed a meal replacement regimen or extreme caloric restriction diet (considered lower than 60% normal caloric intake) in the last 30 days.
- •5.Individuals with known or suspected intolerance or hypersensitivity to soya beans, the product ingredients (or closely related compounds) or any of their stated ingredients i.e., Nicotinamide Riboside Chloride, Magnesium, Vitamin E, Selenium, Turmeric and Black Pepper.
- •6.Individuals who have participated in any other interventional study or have received any investigational drug within 30 days of the screening.
- •7.Individuals categorised as an elite athlete by their National Sporting Organisation (NSO) or another relevant organisation.
- •8.Individuals who abuse substances (i.e., alcohol, cannabis, hallucinogens, cocaine, opioids, and sedatives)
- •9.Individuals who do not agree to limit their alcohol consumption as per the Australian guidelines (i.e., no more than 10 standard drinks a week and no more than 4 standard drinks on any one day) during the study period.
- •A standard drink contains 10 grams of pure alcohol. Standard drink examples are the following:
- •Light beer (2.7% alc/vol) 425 mL
- •Mid strength beer (3.5% alc/vol) 375 mL
- •Full strength beer (4.9% alc/vol) 285 mL
- •Regular cider (4.9% alc/vol) 285 mL
- •Sparkling wine (13% alc/vol) 100 mL
- •Wine (13% alc/vol) 100 mL
- •Fortified wine e.g., sherry, port (20% alc/vol) 60 mL
- •Spirits e.g., vodka, gin, rum, whiskey (40% alc/vol) 30 mL
- •10.Personnel:
- •i.An employee of the sponsor or the study site or members of their immediate family
- •ii.A person who is engaged in the production, marketing or supply of the goods (a relevant person);
- •iii.A person who is engaged in the marketing or supply of therapeutic goods includes influencers, direct sellers and other persons who have, or will receive, valuable consideration for making the testimonial.
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