NCT05723497已完成不适用
Supporting Local Agriculture Via Clinical Research: Human Studies With Elderberries to Improve Biomarkers of Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Glucose tolerance/insulin sensitivity
研究概览
简要总结
Previous studies in humans indicate that anthocyanin-rich berries can positively alter fat oxidation and insulin sensitivity. This study will determine if this is also true with elderberries, which are a more concentrated source of anthocyanins compared to other commonly consumed berries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.
排除标准
- •Are not fully vaccinated against COVID-19 (at least 2-weeks out from final dose at time of staff meeting)
- •Have a body mass index less than 25 kg/m2
- •Are younger than 22 years of age, or older than 75 years of age
- •Pregnant, lactating, or intending to become pregnant during the study period, or have given birth in the past year
- •Known allergy or intolerance to elderberries
- •History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study
- •Adherence to restrictive (vegetarian or vegan) or extreme (fad [ex. Ketogenic or Atkins] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight
- •Habitual use of tobacco or marijuana (including vaping) products in the last 6 months
- •Diagnosis or treatment of cancer in the past 3 years
- •Crohn's disease or diverticulitis
- •Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- •Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
- •Type 2 diabetes requiring the use of medication
- •Fasting blood glucose > 125 mg/dL
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Glucose tolerance/insulin sensitivity
时间窗: 3 hours
Blood will be collected following a meal tolerance test
Substrate oxidation
时间窗: 3.5 hours
Participants will be monitored by a metabolic cart at rest and while walking
次要结局
未报告次要终点
研究者
Patrick Solverson
Assistant Professor
Washington State University
研究点 (2)
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