ACTRN12616000110482已完成未知
Evaluating a meal replacement program (Impromy) for accelerated weight loss and greater program retention in overweight adults..
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- CSIRO
- 入组人数
- 164
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1.Adults with a BMI greater than or equal to 27kg/m2;
- •2.Aged 25-60 years;
- •3.Willing to attend CSIRO SAHMRI clinic in Adelaide on 10 occasions;
- •4.Willing to participate in the study including collection of blood samples on 2 occasions, and completing questionnaires,
- •5.Willing to follow a weight loss dietary protocol for 16 weeks plus weight maintenance dietary protocol a further 8 weeks;
- •6. Non-smoker;
- •7. Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.
排除标准
- •1. Any known pre-existing, diagnosed medical condition (assessed by self report in the screening medical questionnaire) that may prevent them from participating in the study, including but not limited to:
- •a. Kidney disease or renal impairment;
- •b. Gall bladder disorders or stones;
- •2.Regular use of prescribed weight loss medications; or medications that contain Mono-amine oxidase inhibitors, Lithium, Anticoagulants e.g. Warfarin.
- •3.Regular use of any other medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process;
- •4.A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol;
- •5.A score of greater than or equal to 2 on the SCOFF screening questionnaire for eating disorders*;
- •6.A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;
- •7.Women who are attempting to become pregnant, pregnant, lactating, (postmenopausal women should not change HRT regimen during the study);
- •8.Participation in another study within 30 days of commencement of the present study.
- •a.Liver disease (e.g. cirrhosis);
- •b.Angina, chest pain (undiagnosed) or severe shortness of breath;
- •c.Diagnosed cardiovascular disease;
- •d.Cardiac arrhythmia, heart disease, heart attack, coronary bypass surgery;
- •f.Dementia;
- •g.Thyroid disease;
- •i.Gastrointestinal disease (including celiac or malabsorption diseases Crohns disease);
- •j.History of bariatric surgery;
- •k.Epilepsy;
- •l.Neurological or psychiatric conditions;
- •m.Severe depression;
- •n.Cancer (unless benign or non-progressive skin cancer);
- •o.Type 1 or type 2 diabetes.
研究者
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