NCT04763473已完成不适用
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Glycemic response
研究概览
简要总结
This two-arm, double blind, randomized clinical trial will compare the effect of an avocado extract, compared to placebo, on cardiometabolic outcomes in adults with obesity.
详细描述
Sixty eligible participants will be stratified by sex and randomly assigned to placebo or avocado extract supplementation group for 12 weeks. Metabolic testing will be performed at baseline, and at the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 25 - 65 years old
- •Waist circumference (>94cm in men and >80cm in women)
- •BMI 30 - 40 kg/m2
- •Willingness to provide written informed consent and willingness to participate and comply with the study
排除标准
- •Women planning pregnancy during the course of the study or 3 months after completion of the study, or who are lactating
- •Individuals diagnosed with type 1 or type 2 diabetes mellitus, liver or kidney diseases, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac), cardiovascular event in the previous 6 months, or any other condition deemed unstable
- •Biochemical abnormalities or evidence at screening of disease including elevated liver enzymes ALT and/or AST >3 times normal range limit
- •Not weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry).
- •Current or recent (within 12 months) treatment with medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. domperidone, cisapride, orlistat, phentermine, topiramate). Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone), thyroxine, corticosteroids, anti-depressants (selective serotonin reuptake inhibitors), anti-hypertensives (ace-inhibitors, calcium channel blockers, beta-blockers, diuretics) and lipid lowering medications (statins, fibrates) will not be excluded.
- •Participants who have had bariatric surgery
- •Participants with conditions that may interfere with the ability to understand the requirements of the study.
结局指标
主要结局
Glycemic response
时间窗: 12 weeks
Change in glucose area under the curve (AUC) in response to 75 g oral glucose tolerance test
次要结局
- C-reactive protein(12 weeks)
- Fasting glucose(12 weeks)
- Body weight(12 weeks)
- Body composition(12 weeks)
- Blood pressure(12 weeks)
- Blood lipids(12 weeks)
- Oxidative stress(12 weeks)
- Postprandial insulin(12 weeks)
- Waist circumference(12 weeks)
- Homeostatic model assessment of insulin resistance (HOMA-IR)(12 weeks)
- Fasting insulin(12 weeks)
- Autophagy(12 weeks)
研究者
A/Prof Leonie Heilbronn
Associate Professor
University of Adelaide
研究点 (2)
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