Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Substrate oxidation
研究概览
简要总结
The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Double (ParticipantOutcomes 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
- •Pregnant or trying to become pregnant
- •Have a body mass index less than 25 kg/m2
- •Are younger than 22 years of age, or older than 75 years of age
- •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 (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
Substrate oxidation
时间窗: 3.5 hours
Participants will be monitored by a metabolic cart at rest and while walking
Glucose tolerance/insulin sensitivity
时间窗: 3 hours
Blood will be collected following a meal tolerance test
Gut Microbiome analysis
时间窗: 5 minutes
Feces will be collected before and after the intervention
次要结局
未报告次要终点