ACTRN12623001081606终止Unknown
Project ULTI: Evaluating the effect of the reformulated Ultivite and Ultivite 50 plus Multivitamin on energy, fatigue and cognitive function in healthy adults, which may then be used for advertising claims.
试验速览
- 阶段
- Unknown
- 状态
- 终止
- 入组人数
- 457
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
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Participants must meet all inclusion criteria in order to be eligible to participate in the study:
- •1.Consent to participate in the research, collect data, receive product for trial.
- •2.Aged between 18 and 65 years, both inclusive.
- •3.Good general health based on a self-reported absence of any chronic health condition or co-morbidities and the absence of any medication relating to such conditions (e.g. diabetes, etc.). The only allowed medication is contraceptives. For the 18-50yo group, participants taking medication for hypertension and hypercholesterolemia will also be included. Note: Stable medically managed hypertension (HTN) or hypercholesterolaemia is a stable and chronically managed condition. It is unlikely to cause any significant interference with trial primary or secondary outcomes.
- •4.Body mass index (BMI) lower than 35 kg/m2
- •5.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 2 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 every occasion or are surgically sterile (oophorectomy, hysterectomy or tubal ligation) or
- •agree not to have unprotected sexual intercourse throughout the study duration.
- •6. Individuals who agree to continue their usual” exercise routine for the duration of the study.
排除标准
- •Participants meeting any of the following criteria will not be eligible to participate in the study:
- •1.Individuals with medical conditions (absolute contraindications): narcolepsy, chronic fatigue, long covid, depression, heart failure, renal impairment, liver impairment (ASA 1 patients).
- •2.Individuals with identified nutritional deficiencies, particularly iron and B12.
- •3.Individuals currently taking any other herbal supplements (however, participants as such who cease usage 1 month prior to study commencement can be included) – Applicable to 51-65yo group.
- •4.Individuals who are pregnant and/or lactating, or who are planning to become pregnant during the study or four weeks after the study
- •5.Individuals who are currently taking any other supplement (e.g., (multi)vitamins, minerals, omega-3 fatty acids (EPA, DHA, ALA), fibre, herbal.) - Applicable to 51-65yo group.
- •6.Individuals currently taking any supplements like Multivitamins, B vitamins, and/or any other supplements (vitamins/minerals or herbals) that target physical energy and/or mental stamina. Patients who are long term (>4weeks) stable supplement therapy, where the supplement is not known to have any interaction, is unlikely to have any effect on primary or secondary outcomes. Stable therapy forms part of their baseline where the trial will essentially measure the deviation from this baseline. (Also, participants as such who cease usage 2 weeks prior to study commencement can be included). - Applicable to 18-50yo group.
- •7.Individuals with known or suspected intolerance or hypersensitivity to the product ingredients (or closely related compounds) or any of their stated ingredients.
- •8.Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- •9.Individuals categorised as an elite athlete by their National Sporting Organisation (NSO) or another relevant athletic organisation.
- •10.Individuals who use substances (i.e., alcohol, cannabis, hallucinogens, cocaine, opioids, and sedatives)
- •11.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.
- •12.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.
- •IV.A member of a relevant person’s immediate family, unless the advertisement discloses that the person who made the testimonial is an immediate family member of the relevant person;
- •V.Employees or contractors of a government or government authority, a hospital, or healthcare facility, other than a community pharmacy;
- •VI.A current or former health practitioner, health professional or medical researcher;
- •VII.A person who represents themselves as being qualified or trained to diagnose, treat or prevent disease, ailment, defect or injury in persons.
- •Please note, V, VI & VII are applicable to 51-65yo group participants only.
- •For the 18-50yo group, these exclusions have been relaxed to facilitate recruitment. These changes are representativ
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